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PST Level 6 Semester 2

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06211 Monitoring and Evaluation of Medicine Use

The Concept of Pharmacovigillance – PST06211 Monitoring and Evaluation of Medicine Use

NTA Level 6 • Semester 2 • PST06211 The Concept of Pharmacovigillance Monitoring and Evaluation of Medicine Use • Source Session/Topic 8 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 8: The Concept of Pharmacovigillance: Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain pharmacovigillance • Define terminologies used in pharmacovigillance • List the aims of pharmacovigillance • List key partners in pharmacovigillance • Explain the importance of pharmacovigillance Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Computer and LCD projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 2 05 minutes Presentation Explanation of Pharmacovigillance 3 15 minutes Presentation Definition of Terms in Pharmacovigillance 15 minutes Presentation and 4 Aims of Pharmacovigillance Buzzing 5 10 minutes Presentation Key Partners in Pharmacovigillance 50 minutes Presentation and 6 Importance of Pharmacovigillance Group discussion 7 10 minutes Presentation Key Points 8 10 minutes Presentation Evaluation PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 62 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Pharmacovigillance(5 minutes) • The etymological roots for the word "pharmacovigillance" are: pharmakon (Greek for drug) and vigilare(Latin for to keep watch). As such, pharmacovigillance heavily focuses on adverse drug reactions. • Pharmacovigillance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem(According to WHO definition) • Why Pharmacovigillance is needed? The processes involved in the clinical development of medicines once put onto the market; a medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population. At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. STEP 3: Definition of Terms in Pharmacovigillance (15 minutes) The following are some of pharmacovigillance terminologies as adopted in TFDA guideline: • Adverse Drug Reactions (ADRs) a response to a medicinal product that is noxious or potentially harmful and unintended and which occurs at doses normally used in human for prophylaxis, diagnosis or therapy of a disease or for the modification of physiological function in which individual factors may play an important role. • Adverse eventAny unfavourable medical occurrence that in coincidence may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with the treatment. • Benefit/risk analysis Examination of the favourable and unfavourable results of undertaking a specific course of action. • Life-threatening reaction isa reaction in which the patient was at risk of death at the time of the event and does not refer to an event, which hypothetically might have caused death if it was more severe. • Serious adverse drug reaction A noxious and unintended response to a drug that at any dose, may result in death, is life threatening (such as Stevens-Johnson Syndrome), requires patient hospitalization or prolongation of existing hospitalization, causes a congenital PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 63 anomaly or birth defect, results in persistent or significantly is ability or incapacity, or require intervention to prevent permanent impairment or damage. • Side effect any unintended effect of a pharmaceutical product occurring at doses used in man for medical treatment which is related to the pharmacological properties of the product and in which there is no deliberate overdose. • Unexpected adverse drug reaction An adverse reaction, the nature or severity of which is not mentioned in the summary of product characteristic or market authorization, or expected from characteristics • Biological products Medical products prepared from biological material of human, animal or microbiologic origin (such as blood products, vaccines, insulin). • Clinical trial A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining their efficacy and safety. • Efficacy The ability of a drug to produce the intended effect as determined by scientific methods, for example in pre-clinical research conditions (opposite of hazard). • Potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity. • Individual case safety reports (ICSR)A report that contains ‗information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient. • Post-marketing The stage when a drug is generally available on the market. • Pre-marketing The stage before a drug is available for prescription or sale to the public. • Poly-pharmacy The concomitant use of more than one drug, sometimes prescribed by different practitioners. • Placebo An inactive substance (often called a sugar pill) given to a group being studied to compare results with the effects of the active drug. • Cohort study – A study that identifies defined populations and follows them forward in time, examining their rates of disease. • National pharmacovigillance centre – A single, governmentally recognized centre within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety. PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide 64 STEP 4: Aims of Pharmacovigillance (15 minutes) Activity: Buzzing (5minutes) ASK students to pair up and buzz on the following questions for 5 minutes • What are the aims of pharmacovigillance? ALLOW few pairs to

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Data Processing – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Data Processing Operational Research • Source Session/Topic 22 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 22: Data Processing Total Session Time: 120 minutes + 240 minutes assignment Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  Categorize the data  Code the data  Summarize the data in data master sheets  Compile the data manually without master sheets Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks Presentation 2 20 minutes Group Categorizing the Data discussion 20 minutes Presentation 3 Coding the Data Brainstorming 30 minutes 4 Presentation Summarizing the Data in Data Master Sheets 35 minutes 5 Presentation Compiling the Data Manually without Master Sheets 6 05 minutes Presentation Key Points 7 05 minutes Presentation Evaluation ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 221 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Categorizing the Data (20 minutes) Activity: Small Group Discussion (20 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • How are the data categorized? ALLOW students to discuss for 10 minutes ALLOW few groups to present and the rest to add points not mentioned CLARIFY and SUMMARIZE by using the contents below • In data processing following important issues should be considered: o Sorting data o Performing quality-control checks o Data processing o Data analysis • Sorting Data o An appropriate system for sorting the data is important for facilitating subsequent processing and analysis. o If you have different study populations (for example village health workers, village health committees and the general population), number the questionnaires separately. o In a comparative study sort the data right after collection into the two or three groups that will be compared during data analysis. • Performing Quality Control Checks o Checked in the field to ensure that all the information has been properly collected and recorded. o Before and during data processing, the information should be checked again for completeness and internal consistency. o If a questionnaire has not been filled in completely you will have missing data for some of the variables. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 222 o If there are many missing data in a particular questionnaire, the decision may be to exclude the whole questionnaire from further analysis. o If an inconsistency is clearly due to a mistake made by the researcher/research assistant o For example, if a person in an earlier question is recorded as being a non-smoker, whereas all other questions reveal that he is smoking, it may still be possible to check with the person who conducted the interview and to correct the answer. • If the inconsistency is less clearly a mistake in recording, it may be possible (in a small scale study) to return to the respondent and ask for clarification. • If it is not possible to correct information that is clearly inconsistent, consider excluding this particular part of the data from further processing and analysis as it will affect the validity of the study. • If a certain question produces unclear answers throughout, the whole question should be excluded from further analysis. (Normally, however, you would discover such a problem during the pre-test and change the wording of the question.) • The Questions to be answered before Processing o Have the data been sorted appropriately? o Have questionnaires been numbered? o Major categories of informants distinguished? o Have quality checks been performed? For completeness and consistency of information? o Has all qualitative data been categorized as far as possible? • Data Processing – Quantitative Data o Decide on the method for processing and analyzing data from questionnaires  Manually, using data master sheets or manual compilation of the questionnaires  By computer, for example, using micro-computer and existing software or self- written programmes for data analysis • Data processing in both cases involves o Categorizing/classifying the data o Coding o Summarizing the data in data master sheets, manual compilation without master o sheets, or data entry and verification by computer • Categorizing/Classifying Data o Decisions have to be made concerning how to categorize responses. o Categorical variables that are investigated through closed questions or observation, the categories are decided earlier. o In interviews the answers to open-ended questions, the answers can be pre- categorized to a certain extent, depending on the knowledge of possible answers that may be given.  Answers that are difficult or impossible to categorize may be put in a separate residual category called ‗others‘, but this category should not contain more than 5% of the answers obtained. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 223 • For numerical variables, the data are often better collected without any pre-categorization. • If you do not exactly know the range and the dispersion of the different values of these variables when you collect your sample (e.g., home-clinic distance for out-patients, or income), decisions concerning how to categorize and code the data at the time you develop your tools may be premature. • If you notice during data analysis that your categories had been wrongly chosen you cannot reclassify the data anymore. STEP 3: Coding the Data (20 minutes) Activity: Brainstorming (05 minutes) Ask students to brainstorm on the following question: • How are the data coded? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Coding o If

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Data Collection – Field Work Activities – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Data Collection – Field Work Activities Operational Research • Source Session/Topic 21 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 21: Data Collection – Field Work Activities Total Session Time: 480 minutes Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  Identify activities to be done before data collection  Collect data  Process data while in the field Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1. 05 minutes Presentation Introduction, Learning Tasks Presentation 2. 15 minutes Activities to be done before data collection Buzzing Presentation 3. 20 minutes Lecture Data collection discussion Presentation 4. Data processing 10 minutes Brainstorming 5. 05 minutes Presentation Key Points 6. 05 minutes Presentation Evaluation 7. 05 minutes Presentation Field wok –data collection ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 216 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Activities to be Done before Data Collection Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes  What are the activities to be done before data collection? ALLOWS few groups to respond WRITE their responses on the flipchart or board CLARIFY and SUMMARIZE by using the content below  Briefing managers, health service personnel and community members concerned  Identifying and obtaining resources for the study  Reviewing availability of subjects and information  Organizing logistics for data collection  Preparing field work manuals (if necessary)  Training of research team members, including assistants  Conducting the pre-test in the research location, with preliminary data analysis and revision of data-collection tools (if was not done) STEP 3: Data Collection Having obtained permission for the study, and having  obtained the necessary resources,  trained the team members,  organized the logistics, and  Pre-tested and modified the data-collection tools and procedures, the data collection can now be carried out. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 217 STEP 4: Data Processing After collecting and sorting the data, all data should be checked for errors. The content may be converted into codes or keywords for processing by computer or using master sheets. The steps during this process include: 1. Editing/cleaning, 2. Categorizing and coding, 3. Summarizing data on data master sheets, or 4. If a computer is used, writing instructions to the computer analyst concerning data input and analysis. STEP 5: Key Points • Before one collects data, preparation is very important in terms of informing relevant authorities and seeking permission, preparing logistics and thing of staring data processing while in the field. STEP 6: Evaluation • What are the important preparations one will do before embarking in data collection? STEP 7: Field work – data collection Arrange areas for students to go and collect data using tools and techniques they have identified. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 218 References Hardon A, Boonmongkon P, and Streefland P. et al (2001). Applied Health research, Anthropology of health and health care, (3rd Ed) Amsterdam, The Netherlands: Het Spinhuis Publishers Beaglehole R, Bonita R and Kjellstrom (1993) Basic epidemiology: Geneva, Switzerland: World Health Organization, Kothari C.R (1985). Research Methodology – Methods and techniques, (2nd ed); New Delhi, India; Wiley Eastern Limited Stewart A (2001). Basic Statistics and epidemiology, A practical guide,; London, United Kingdom: Radcliffe Medical Press, Varkevisser, C. M, Pathmanathan, I and Brownlee, A (1991). Designing and Conducting Health Systems Research Projects, Vol. 2 Part I: Ottawa, Canada: IDRC Polit, D. F and Beck, C. T (2004). Nursing Research – Principles and Methods, (7th Ed): Philadelphi, USA: Lippincott Williams & Wilkins, ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 219 ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 220 ← Previous TopicNext Topic →View all Operational Research topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP WhatsApp: 255620339260

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Data Collection – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Data Collection Operational Research • Source Session/Topic 20 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 20: Data Collection Total Session Time: 60 minutes + 360 minutes Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  Review previous data-collection techniques  State the uses and limitations of different data collection methods  Mention issues to consider in selecting data collection methods  List advantages of using a combination of different data collection techniques  Explain difference between data collection methods and tools  Identify various sources of bias in data collection and ways of preventing Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks Presentation 2 10 minutes Various Data-Collection Techniques Buzzing Presentation 3 Group The Uses and Limitations of Different Data Collection 35 minutes discussion Methods 4 Presentation Issues to Consider in Selecting Data Collection 10 minutes Methods 5 Presentation Advantages of Using a Combination of Different Data 10 minutes Collection Techniques 6 Presentation Difference between Data Collection 25 minutes Methods/techniques and Tools 7 Presentation Sources of Bias in Data Collection and Ways of 15 minutes Preventing ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 207 8 05 minutes Presentation Key Points 9 05 minutes Presentation Evaluation SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Various Data-Collection Techniques (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes  What are various data-collection techniques ALLOWS few students to respond WRITE their responses on the flipchart or board CLARIFY and SUMMARIZE by using the content below  Data-collection techniques o Use of available information o Observation o Interview o Administering a questionnaire o Focus group discussion o In-depth interview ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 208 STEP 3: Uses and Limitations of Different Data Collection Methods (35 minutes) Activity: Small Group Discussion (20 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • What are the uses and limitations of different data collection methods? ALLOW students to discuss for 10 minutes ALLOW few groups to present and the rest to add points not mentioned CLARIFY and SUMMARIZE by using the contents below  Use of available information o Means: Looking into records and extracting information o Advantages  Cheaper since information is already there  Doesn't depend on respondent‘s willingness to respond  Allow observation of trend o Disadvantages  May be difficult to access the data  Information may be incomplete or imprecise  Ethical concerns regarding confidentiality may arise  Observation o Means: Watching and recording, no talking with respondent o advantages  Gives information of what is currently happening  Doesn't depend on respondent‘s willingness to respond  Disadvantages  Observer may notice only what interests him/her (bias)  Presence of observer may influence behaviour of respondent  Ethical concerns regarding confidentiality may arise  Interview o Means: Asking a respondent questions orally o Advantages ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 209  Can be used for illiterates  Allows clarification of questions  Higher response rate o Disadvantages  Expensive (time, human resources)  Presence of interviewer may influence response  Administering a questionnaire o Means: giving respondents written questions (questionnaire) so that they read the questions themselves and provide answers o Advantages  Quick and cheap, no many research assistants needed  Allows anonymity, hence more honest responses o disadvantages  Require literate respondents  Response rate could be low  Questions may be misunderstood by respondents  Some respondents may choose responses simply because they saw it there, otherwise they wouldn't have thought of it  Focus group discussion o Means: A discussion of a topic by a group of selected persons guided by a facilitator o Advantages  Flexibility to explore new issues that arises  Findings are more believable  Relatively cheaper o Disadvantage  Discussion could base on irrelevant issues  Minority opinion may not be expressed  Difficult to analyse the data  Require highly trained moderator  In-depth interview o Means: A person to person conversation in order to gain insight into people's thoughts, feelings, and behaviour on important issues o Advantages  Collects large amount of data quickly  Allows clarification of issues o Disadvantages  Needs skilled interviewer  Data difficult to analyse  Views could be subjective STEP 4: Issues to Consider in Selecting Data Collection Methods (10 Minutes) ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 210  Objectives of the study  Nature of required information (quantitative or qualitative)  Resources available (time, money, personnel)  Acceptability of the method by respondents ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 211 STEP 5: Advantages of Using a Combination of Different Data Collection Techniques (10 minutes) • Data collection techniques can complement each other. • A skillful use of a combination of different techniques can reduce the chance of bias and give a more comprehensive understanding of the topic under study. • Researchers often use a combination of flexible and less flexible research techniques. • Flexible techniques include: o Loosely structured interviews using open-ended questions. o Focus group discussions. o Participant observations are also called qualitative research techniques. o They produce qualitative data that is often recorded in narrative form. • Qualitative Research Techniques o Involve the identification and exploration of a number of often

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Research Budget – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Research Budget Operational Research • Source Session/Topic 19 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 19: Research Budget Total Session Time: 120 minutes + 240 minutes assignment Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  Identify the important points to be considered when starting to plan for data collection  Determine what resources are available and needed to carry out the research  Describe the activities of the research  Cost the research activities, materials and supplies required Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Objectives Identification of Important Points to be Presentation 2 15 minutes Considered when Starting to Plan for Data Buzzing Collection Presentation Determination of Resources Available and 3 10 minutes Brainstorming Needed to Carry Out the Research 4 25 minutes Presentation Activities of the Research 50 minutes Presentation Costing the Research Activities, Materials and 5 Group discussion Supplies Required 6 05 minutes Presentation Key Points 7 05 minutes Presentation Evaluation 8 05 minutes Presentation Assignment ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 197 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Identification of Important Points to be Considered when Starting to Plan for Data Collection (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes:  What are the important points to be considered when starting to plan for data collection? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below  The most important points to be considered when starting to plan for data collection: o It should be simple, realistic, and easily understood by those directly involved. o It should cover the preparatory and the implementation phases of the project, as well as data analysis, reporting, dissemination and utilization of results. o The activities covered should include training, technical or research tasks; administrative, secretarial and other support tasks. o The realities of local customs (local holidays, festivals) and working hours should be considered, when preparing the work plan. o Also, seasonal changes and their effect on travel, work habits, and on the topic you are studying (such as incidence of disease or nutritional status), should be kept in mind as the schedule is planned. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 198 STEP 3: Determination of Resources Available and Needed to Carry Out the Research (10 minutes) • Base on the work plan • Specify for each activity in the work plan, what resources and inputs are required • For each resource determine unit cost and, number of units to get the total cost STEP 4: The Activities of the Research (30 minutes) • Research activities include: o Finalize research proposal and submit to ethical committee for clearance o Translate questionnaires, typing, multiplying o Recruit research assistants o Obtain clearance and orient of DMOs, health institutions and village health workers o Train research assistants o Pre-test study o Collect data o Process data and make preliminary interpretation o Analyze data and write report o Disseminate and discuss research findings and preliminary recommendations with community members, health staff o Disseminate and discuss of research findings and preliminary recommendations with policymakers/managers/ others o Draft preliminary plan of action o Hold meetings with policy makers/managers/others to discuss plan of action for implementing recommendations o Follow up on implementation of plan of action STEP 5: Costing the Research Activities, Materials and Supplies Required (50 minutes) Activity: Small Group Discussion (5 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • What research activities, materials and supplies required in the study need to be budgeted? ALLOW few students to respond ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 199 WRITE their responses on flipchart or board CLARIFY and SUMMARIZE by using the contents below • Purpose of a Budget o A detailed budget will help to identify which resources are already locally available and which additional resources may be required. o The process of budget design will encourage you to consider aspects of the work plan you have not thought about before o Serve as a useful reminder of activities planned, as your research gets underway. • Budget Preparation o A complete budget is not prepared until the final stage of project planning.  Cost is usually a major limiting factor and therefore must always be kept in mind during planning so that your proposals will not have an unrealistically high budget. o Remember that both ministries and donor agencies usually set limits for research project o budgets. o The use of locally available resources increases the feasibility of the project from a financial point of view. • Categories for a Budget o Funds for personnel allowances for researchers, and assistants during training research assistants, field work piloting and actual study o Funds for secretarial services e.g. typing the proposal and questionnaires, final report and dissemination o Funds for transport number of visits and kilometers to be covered, funds for supplies. o Stationary and lunch for those attending FGD, meetings o 5% for emergency • Making Reasonable Estimates in a Budget o Do not underestimate the time needed to complete project tasks in ‗the real world‘. o Include a 5% emergency fund if you fear that you might have budgeted for the activities rather conservatively.

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Data Collection Plan – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Data Collection Plan Operational Research • Source Session/Topic 18 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 18: Data Collection Plan Total Session Time: 120 minutes + 240 minutes assignment Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  Describe problems that may arise during data collection and how they may be solved.  Prepare a plan for data collection for the developed research proposal  Determine the various tasks of the staff needed for research  Prepare a work schedule (GANTT chart)  Draw a work schedule (GANTT chart) Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector  Handout 18.1: Example of a GANTT  Handout 18.2: Example of a work schedule SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks Presentation 2 15 minutes Typical Problems that May Arise During Data Buzzing Collection and Solutions. 3 10 minutes Presentation Preparation of a Plan for Data Collection for the Developed Research Proposal Presentation 4 25 minutes Group Determination of Various Tasks of the Staff Needed for discussion Research 5 Presentation Preparation of a Work Schedule (GANTT Chart) 25 minutes 6 Presentation Drawing a Work Schedule (GANTT Chart) 25 minutes 7 05 minutes Presentation Key Points ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 182 8 05 minutes Presentation Evaluation 9 05 minutes Presentation Assignment SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Typical Problems that May Arise During Data Collection and Solutions (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes ASK What problems may arise during data collection and their solutions ALLOWS few students to respond WRITE their responses on the flipchart or board CLARIFY and SUMMARIZE by using the content below • Possible problems Sources of data distortion (bias) that might include: o Deviations from the sampling procedures set out in the proposal. o Variability or bias in observations or measurements made because  Research assistants are placed under too much stress  Inadequate supervision of research assistants.  Questionnaire not filled in completely • Solutions o Training research assistant o Pretest instrument o Adequate supervision of data collection o Revise method to check quality of data ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 183 o Prior anticipation of problems that might occur and prepare plan to overcome them STEP 3: Preparation of a Plan for Data Collection for the Developed Research Proposal (10 minutes) • A Plan for Data Collection o Listing the tasks that have to be carried out, and who should be involved, o Making a rough estimate of the time needed for the different parts of the study o Identifying the most appropriate period in which to carry out the research. o Scheduling the different activities that have to be carried out each week in a work plan. • Pre-Testing o Before the proposal development is finished, a pre-test of the data collection and data analysis procedures should be made. o The advantages of conducting a pre-test before the proposal is that we can draft the work plan and budget based on more realistic estimates, as well as revise the data collection tools before we submit the proposal for approval. o However, further pre-testing and planning of the research have to be done in the field. • Stages in the Data Collection Process o Stage 1: Permission to proceed o Stage 2: Data collection o Stage 3: Data handling • Stage 1: Permission to Proceed o Consent must be obtained from the relevant authorities, individuals and the community in which the project is to be carried out.  This may involve organizing meetings at national or provincial level, at district and at village level. o For clinical studies this may also involve obtaining written informed consent. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 184 o The principal investigator will be responsible for obtaining permission to proceed at the various levels. o The Health Research Unit in the Ministry of Health or the institution organizing the course may assist in obtaining permission from the national level. • Stage 2: Data Collection o During data collection consider:  Logistics: who will collect what, when and with what resources  Quality control (data must be reliable and valid) o When allocating tasks for data collection, it is recommended that first list type of data required. o Identify who could best implement each of the tasks.  If it is clear earlier that your research team will not be able to carry out the entire study by itself  Plan to look for research assistants to assist in relatively simple but time- consuming tasks. Consider the following: • Time for Data Collection o Think about how long will it take to collect data for each component of the Study?  The time required to reach the study area(s)  The time required locating the study units (persons, groups, records), search for specific informants (e.g., users or defaulters of a specific service)  It might take more time to locate informants than to interview them; consider the number of visits required per study unit. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 185 o Calculate the number of interviews that can be carried out per person per day (e.g. 4) o Calculate the number of days needed to carry out the interviews. For example: You need to do 200 interviews o Your research team of

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Pre-Testing the Research Tools – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Pre-Testing the Research Tools Operational Research • Source Session/Topic 17 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 17: Pre-Testing the Research Tools Total Session Time: 60 minutes + 240 minutes assignment Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  Define pretest and pilot study  Outline reasons for pretest  Describe the components of a pre-test  Plan and carry out pre-test of research components Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector  Handout 17.1: Summary of points to assess during a pre-test or pilot study SESSION OVERVIEW Activity/ Step Time Content Method 1. 05 minutes Presentation Introduction, Learning Tasks Presentation Definition of Pre-test and pilot study 2. 05 minutes Brainstorming Presentation Reasons for pretesting 3. 10 minutes Lecture discussion Presentation 4. 15 minutes Components of a Pre-Test and Pilot Study Buzzing 10 minutes Presentation 5. Planning and Carrying out Pre-Test of Research Buzzing Components 6. 05 minutes Presentation Key Points 7. 05 minutes Presentation Evaluation 8. 05 minutes Presentation Assignment ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 173 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Definition of a Pre-Test or Pilot Study (05 minutes) Activity: Brainstorming (2 minutes) Ask students to brainstorm on the following questions:  What are the components of pre-test tools or pilot study? ALLOWS few students to respond WRITE their responses on the flipchart or board CLARIFY and SUMMARIZE by using the content below  A pre-test o Refers to a small-scale trial of particular research components  A pilot study o is the process of carrying out a preliminary study, going through the entire research procedure with a small sample STEP 3: Reasons for Pre-Testing (10 minutes)  Help to identify potential problems in the proposed study.  Enables, if necessary, to revise the methods and logistics of data collection before starting the actual field works.  As a result, a good deal of time, effort and money can be saved.  Pre-testing is simpler and less time-consuming and costly than conducting an entire pilot study. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 174 STEP 4:Components of Pre-Testing (15 minutes) Activity: Buzzing (5 minutes) Ask students to buzz on the following question:  What are the components of pre-test? ALLOWS few students to respond WRITE their responses on the flipchart or board CLARIFY and SUMMARIZE by using the content below  The components of research to be pre-test include: o Reactions of the respondents to the research procedures o The data-collection tools o Sampling procedures o Staffing and activities of the research team o Procedures for data processing and analysis o The proposed work plan and budget for research activities  Reactions of the respondents to the research procedures o Availability of the study population o Study population daily work schedules o Acceptability of the methods used o Acceptability of the questions asked o willingness of the respondents to answer the question  The data-collection tools o Whether the tools can collect the information you need and whether they are reliable o How much time is needed to collect data o Whether there is any need to revise the format or presentation of interview guides/questionnaires e.g.  Sequencing  Wording  Translation  Space for answers  Sampling procedures o Instructions followed o Time need to locate respondents  Staffing and activities of the research team ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 175 o training o Logistics o team work  Procedures for data processing and analysis  work plan and budget for research activities STEP 4: Planning and Carrying Out Pre-Tests of Research Components (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are the components of research that should be assessed during the pre-testing? ALLOW few students to respond WRITE their responses on flipchart or board CLARIFY and SUMMARIZE by using the content below Components of research to be assessed during the pre-testing • During training o The reactions o Appropriateness of study type(s) and research tools o Format and wording of questionnaires and interview schedules o Accuracy of the translations o The time o Sampling procedures Data processing and analysis. • Pre-test in the actual research area o What difficulties do you expect in the implementation of your proposal? o Inexperience with a certain data-collection technique o Which parts of your study will be most costly and time-consuming? • It is highly recommended that you analyse the data collected during the pre-test right away STEP 5: Key Points (5 minutes) • A pre-test refers to a small-scale trial of particular research components ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 176 • A pilot study is the process of carrying out a preliminary study, going through the entire research procedure with a small sample • It is highly recommended that you the pre-test some components of your study STEP 6: Evaluation (5 minutes) • What is a pre-test? • What is pilot study? • What research components are to be pre-tested? STEP 7: Take Home Assignment (5 minutes) Activity: Take Home Assignment (5 minutes) DIVIDE students in groups or individuals ASK the students to work on the following Assignment • Identify what aspects of the study you would like to pre-test in your research area and why, with whom, when and where. • Summarize this information in one or two paragraphs in your research proposal. ALLOCATE

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Developing Research Tools – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Developing Research Tools Operational Research • Source Session/Topic 16 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 16: Developing Research Tools Total Session Time: 120 minutes+240 minutes assignment Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  List common research tools  Identify appropriate data-collection techniques  Prepare data-collection tools  Conduct out an interview Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector  Handout 16.1: Overview of data collection techniques  Handout 16.2: Advantages and disadvantages of various data collection tools  Handout 16.3: Focus Group Discussion (FGD)  Handout 16.4: Functions of FGD Facilitator SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks Presentation Common Research Tools 2 10 minutes Buzzing 3 10 minutes Presentation Identification of Data-Collection Techniques 4 45 minutes Presentation Preparation for Data-Collection Tools 35 minutes Presentation Conducting an Interview 5 Brainstorming 6 05 minutes Presentation Key points 7 05 minutes Presentation Evaluation 8 05 minutes Presentation Assignment ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 131 ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 132 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Common Research Tools (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes:  What are common research tools? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • The quality of research depends on the quality of the data collection tools. The common tools used include questionnaire for interview and checklist • Interviewing and administering questionnaires are probably the most commonly used research techniques. • Designing good questioning and interviewing tools forms an important and time- consuming phase in the development of most research proposals. • The following questions should be considered before designing the tools o What exactly do we want to know, according to the objectives and variables we have? ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 133 o Is questioning the right technique to obtain all answers, or additional techniques, such as observations or analyses of records are needed? o Who to ask questions and what techniques will be used? o Do you understand the topic sufficiently to design a questionnaire, or o Do you need some loosely structured interviews with key informants or a focus group discussion first to orientate ourselves? o Are your informants mainly literate or illiterate? o How large is the sample that will be interviewed? • Before examining the steps in designing a questionnaire, review the types of questions used in interviews. • Depending on how questions are asked and recorded distinguish two major possibilities: o Open-ended questions, (allowing for completely open as well as partially categorized answers). o Closed questions. • Completely Open-Ended Questions o Open-Ended Questions permit free responses which should be recorded in the respondents’ own words. o Open questions are useful for obtaining in-depth information on  Facts with which the researcher is not very familiar.  Opinions, attitudes and suggestions of informants, or Sensitive issues. • Advantages of Completely Open-Ended Questions ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 134 o Allow you to probe more deeply into issues of interest being raised. o Issues not previously thought of when planning the study may be explored, thus providing valuable new insights on the problem. o Information provided in the respondents’ own words might be useful as examples or illustrations, which add interest to the final report. • Risks of Completely Open-Ended Questions o Skilled interviewers are needed to get the discussion started and focused on relevant issues and to record all information collected. o A big risk is incomplete recording of all relevant issues covered in the discussion. o Analysis is time-consuming and requires experience; otherwise important data may be Lost • Suggestions to Improve Use of Completely Open-Ended Questions o Thoroughly train and supervise the interviewers or select experienced research assistants. o Prepare a list of further questions to keep at hand to use to probe for answer(s) in a systematic way. o Pre-test open-ended questions and, if possible, pre-categorize the most common responses • Partially Categorized Questions o In interviews questions are often asked as open-ended questions, but to facilitate ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 135 recording and analysis, some answers can be pre-categorized. For example: ‘How did you become a member of the Village Health Committee?’ Details stated: 1. Volunteered…………………………………………………………………………….. � 2. Elected at a community meeting…………………………………………………. � 3. Nominated by community leaders…………………………………………………� 4. Nominated by the health staff……………………………………………………… � 5. Other (specify): …………………………………………………………………………………………..� In this case the first four categories of answers are known, but there may be other possibilities. Therefore, there is a category ‘other’ where other answers can be recorded. During the analysis, these responses can still be further categorized. o For open-ended questions, more than one answer is usually allowed. • Advantages of Pre-Categorized Answers o Answers can be recorded quickly o Analysis is easier • Risks of Pre-Categorized Answers o If one pre-categorizes too early, a lot of interesting and valuable information may never be recorded or may end up in the category ‘other’. o Interviewers may try to force the information into the categories that are listed and, by merely ticking, this additional valuable information will be lost. o Interviewers may stop after receiving the first answer, whereas more than

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Research Ethics – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Research Ethics Operational Research • Source Session/Topic 15 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 15: Research Ethics Total Session Time: 60 minutes +240 minutes assignment Prerequisites  None Learning Tasks By the end of this session students are expected to be able to:  Define research ethics  Identify areas of research requiring ethical clearance  Describe procedure for research ethical clearance Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 2 10 minutes Presentation Definition of Research Ethics 10 minutes Presentation Areas of research requiring ethical clearance 3 Buzzing 20 minutes Presentation Procedure for Research Ethical Clearance 4 Brainstorming 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation 7 05 Presentation Assignment ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 124 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Definition of Research Ethics (10 Minutes)  Research ethics o Research Ethics is defined here to be the ethics of the planning, conducting, and reporting of research o It is clear that research ethics should include: Protections of human and animal subjects. o ―"ethics": is defined as norms for conduct that distinguish between acceptable and unacceptable behavior‖.  STEP 3: Identification of areas of research requiring ethical clearance (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes  ‘Which areas of research require ethical clearance? ALLOW few students to respond WRITE their responses on flipchart or board CLARIFY and SUMMARIZE by using the content below • In developing data collection techniques, it is important to consider whether the research procedures are likely to cause any physical or emotional harm. • Harm may be caused, by: o Violating informants‘ right to privacy, by posing sensitive questions or by gaining access to records which may contain personal data. o Observing the behavior of informants without them being aware o Allowing personal information (which informants would want to be kept private) to ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 125 be made public. o Failing to observe/respect certain cultural values, traditions or taboos valued by your informants. Using human biological tissue, using human in trial of drugs. • Several methods for dealing with ethical issues are recommended: o Obtaining informed consent before the study or the interview begins. o Do not explore sensitive issues before a good relationship has been established with the informant. o Ensure the confidentiality of the data obtained. Learning enough about the culture of informants to ensure it is respected during the o data collection process. If sensitive questions are asked, for example, about family planning or sexual practices, or about opinions of patients on the health services provided, it is advisable to omit names and addresses from the questionnaires. o Inform participants that they are free to withdraw from the study at any point STEP 4: Procedure for Research Ethical Clearance (20 Minutes) Activity: Brainstorming (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • ‘What are procedures for research ethical clearance? ALLOW few students to respond WRITE their responses on flipchart or board CLARIFY and SUMMARIZE by using the content below  Health research coordination in Tanzania is under the Medical Research Coordinating Committee (MRCC). MRCC is the national health research coordinating body that ensures all health research follows the national health ethics requirements.  Procedure for research ethical clearance o The whole process of receiving, reviewing and approving the protocols takes a maximum of 6 weeks o National Health Research Ethics Committee (NatHREC) carries research monitoring by on-site visits in collaboration with district and regional medical authorities. In this regard, copies of certificates of cleared research proposals are sent to respective District and Regional Medical Officers where research is to be carried out. o Research certificate approval is renewed annually, and PIs are required to submit progress reports biannually. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 126 o To publish the findings, the principal investigator will have to seek permission from the National Institute for Medical Research. o All proposed health research in Tanzania must get an Institutional Ethical approval at the host institution where the research will be based. o In case there is no any Institutional Ethics Committee, the approval will be sought from the NatHREC. o For all health research involving external collaborators (non-Tanzanians), the researchers must apply for the Institutional Ethical Clearance as well as the National Ethics Clearance. o Non-Tanzanian researchers are required by law to get Research Clearance and Research Permit from the Tanzania Commission for Science and Technology (COSTECH) (www.costech.or.tz). o Protocols for Clinical trials to be conducted in Tanzania are reviewed by another specialized sub-committee, Clinical Trials Sub-Committee.  This sub-committee has nine members and meets monthly and reports to the NatHREC. o Clinical trials are required to also obtain a Clinical Trials Certificate from Tanzania Food and Drug Authority (www.tfda.or.tz) before the commencement of the study.  Application procedures o Applicants for research clearance are required to submit application form, Curriculum vitae, Research proposal and three passport size photographs preferably two months before commencement of research. o Permits are given for a period of one year and can be renewed for similar period provided satisfactory progress reports for the previous periods are received by COSTECH. o If and when these formalities have been satisfactorily completed (which may take several months) applicant will receive a formal written offer of a research

Pharmaceutical Sciences Notes, PST Level 6 Semester 2, PST NTA Level 6, PST06210 Operational Research

Determining Sample Size – PST06210 Operational Research

NTA Level 6 • Semester 2 • PST06210 Determining Sample Size Operational Research • Source Session/Topic 14 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 14: Determining Sample Size Total Session Time: 120 minutes + 60 minutes assignment Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • List the issues to consider when deciding on sample size • Calculate the sample size (desirable) • Determine the sample size(s) most appropriate for the research design (feasible) Resources Needed  Flip charts, marker pens, and masking tape  Black/white board and chalk/whiteboard markers  Computer and LCD Projector SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks Presentation 2 15 minutes Issues to Consider when Deciding on Sample Size Buzzing 50 minutes Presentation 3 Calculation of the Sample Size (Desirable) Brainstorming 4 35 minutes Presentation Determination of Sample Size(s) Most Appropriate for the Research Design (Feasible) 5 Key Points 05 minutes Presentation 6 05 minutes Presentation Evaluation 7 05 minutes Presentation Assignment ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 117 SESSION CONTENTS STEP1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: Issues to Consider when Deciding on Sample Size (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes:  What issues should be considered when deciding on sample size? ALLOW few pairs to respond and let other pairs to add on points not mentioned WRITE their response on the flip chart/board CLARIFY and SUMMARIZE by using the content below • There are no fixed rules for sample size in qualitative research. The size of the sample depends on WHAT you try to find out, WHY you try to find out, and HOW you are going to use the data  the sample size depends on the type of problem investigated, required precision and to a certain extent, the resource available  If your research objective is more complex e.g., attitudes of males and females towards family planning, and has policy implications for a larger area, your sample will be bigger.  Very few studies use the whole population (Census)  Most studies use a subset of a population (Sample)  How big should a sample be?  Too large or too little sample is unethical:  Too large: waste resources  Too little: Inconclusive results ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 118 STEP 3: Calculation of the Sample Size (Desirable) (50 minutes) Activity: Brainstorming (10 minutes) Ask students to brainstorm on the following question: • ‘What is the desirable sample size? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Desirable sample size is that calculated using standard formulae • The following general rules may help to determine the desirable sample size of any given study: o The desirable sample size depends on the expected variation in the data (of the most important variables): the more varied the data are, the larger the sample size we would need to attain the desired level of accuracy. o The desirable sample size also depends on the number of cells we will have in the cross-tabulations which we need to analyze the results.  A rough guideline is to have at least 5 to 10 study units per cell o How big can be calculated. Still, the desirable sample size cannot always be achieved for lack of resources such as time, manpower and money.  This constraint applies to quantitative as well as qualitative studies  Therefore, the eventual sample size is usually a compromise between what is desirable and what is feasible o Sample size calculations ` The following steps should be taken:  Estimate how big the proportion might be (say 80%)  Choose the margin of error you will allow in the estimate of the proportion (say + 10%). This means that, if in the survey indeed 80% of the children are found to be vaccinated, this proportion will probably be between 70 and 90% in the whole study population from which the sample was drawn.  Choose the precision with which you want to be confident that the vaccination coverage in the whole population is indeed between 70 and 90%. You can never be 100% sure. Do you want to be 95% sure? Or 99%? ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 119 o Formulae N = z2PQ d2 N = Minimum sample size Z = Constant, Standard normal deviate (1.96 for 95% Confidence level) P = Population proportion with characteristic of interest Q=1–P d = Acceptable Margin of error STEP 4: Determination of Sample Size(s) Most Appropriate for the Research Design (Feasible) (35minutes)  The feasible sample size determination o Is not calculated, depends on available resources (human, time, money, transport)  Availability of finance: in practice, size of the sample depends upon the amount of money available for the study purposes. This factor should be kept in view while determining the size of sample for large samples result in increasing the cost of sampling estimates o Depends on expected variation in the data: the more varied the data are, the larger the sample size one would need to attain the same level of accuracy o Depends on the number of cells one will have in the cross-tabulations required to analyze the result  A rough guideline is to have at least 20-30 study units per cell o Eventual sample size – is a compromise between desirable and feasible o Nature of study: If items are to be intensively and continuously

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