RESEARCH PROTOCOL

How to prepare a research protocol for NMRR registration

1. Steps of writing a for NMRR registration

2. DEFINITION Proposal: A document to support an application for approval from institution to conduct a study and obtain funding. protocol : A study’s detailed methodology . A simplified protocol is usually part of a research proposal but is not detailed enough to qualify for ethical review.

3. REFERENCES Template-Basic Protocol For Investigator-Initiated Research (http://www.crc.gov.my/clinical-research-documents/) The slides “Essential Elements of a Protocol for Research Involving Human Subjects” by Dr Ho Tze Ming

4. ESSENTIAL COMPONENTS OF A PROTOCOL TITLE PAGE Study title - must match the objective(s) Protocol no., version no. & date - up to you Name & institution of PI Name & institution of Co-I(s) Name & address of Sponsor - grant / self-funding Study site(s) Must match objective(s)

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6. SUMMARY Research synopsis (table form) Study title Study population Study design General objective Specific objective(s) Study endpoints / outcomes Sample size Study duration ESSENTIAL COMPONENTS OF A PROTOCOL

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8. CONTENTS Background and Significance F ind an ample amount of literature review Provide only relevant and current information Information must support issue to be addressed Address the rationale for the study interventions ESSENTIAL COMPONENTS OF A PROTOCOL

9. Objective General objective Specific objective(s) ESSENTIAL COMPONENTS OF A PROTOCOL Example

10. Methodology 3.1 Study Type and Design T ype - aetiology study, diagnostic study, prognostic study , experimental / interventional study Design - observational (cross sectional, cohort, case control), experimental (randomized control trial, interventional case series) Timing - prospective , retrospective State the study endpoints / variables ESSENTIAL COMPONENTS OF A PROTOCOL

11. 3.1 Study Type and Design (cont.) I nterventional study – describe the intervention used If relevant, include: N umber of study groups, ratio of subjects in control & treatment group Specify randomization or blinding if relevant Types, quantity & frequency of biospecimens collected D escribe the instruments used i.e questionnaires (validated?), interviewers (well-trained?) Flow chart (more complex studies) ESSENTIAL COMPONENTS OF A PROTOCOL

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13. 3.2 Study population State where subjects will be recruited from 3.3 Inclusion criteria 3.4 Exclusion criteria 3.5 Withdrawal criteria Relevant for prospective studies (especially RCT) ESSENTIAL COMPONENTS OF A PROTOCOL

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15. 3.6 Sample size Insert calculations & parameters for sample size List the published literature in event of sample size cannot be calculated 3.7 Study Duration and Timeline – start & end dates 3.8 Study Visits and Procedures Relevant for studies with follow ups Studies which collect biospecimens ESSENTIAL COMPONENTS OF A PROTOCOL

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17. 3.9 Statistical Analysis Plan State which statistical test for which variable Statistical software? Confidence level? P lan of accounting for missing, unused & spurious data Include assumption if necessary ESSENTIAL COMPONENTS OF A PROTOCOL

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19. 3.10 & 3.11 Relevant for prospective studies which require informed consent i.e survey, interventional studies - especially RCT 3.10 Risk and benefit to study participants Identify potential / real risks Example : T here are no serious side effects known to be caused by the investigational product. The study procedures are all routine procedures for the condition studied.   Include benefits to participant / overall research Example : This study does not present any direct benefit to the participants but may provide a better understanding of the condition studied. ESSENTIAL COMPONENTS OF A PROTOCOL

20. 3.11 Risk Benefit Assessment Provide a brief risk benefit assessment Strong justification - if the risk outweighs the benefits State how study related injuries are treated & who pays for the treatment Example : There is minimal risk from the investigational product and study procedures. Study findings shall greatly improve treatment outcomes. The expected benefit outweighs the minimal risk and thus this study should be supported. If any injuries occur as a result of participating in the study, treatment for shall be provided or paid for by the sponsor. ESSENTIAL COMPONENTS OF A PROTOCOL

21. 3.12 Ethics of Study Must comply with ethical principles - Declaration of Helsinki and GCP If study includes vulnerable subjects - pregnant women , children, prisoners, cognitively impaired, critically ill subjects), include a justification & state they will be protected   3.13 Informed Consent/Assent Process State where, when and process for obtaining informed consent/assent ESSENTIAL COMPONENTS OF A PROTOCOL

22. 3.14 Privacy and Confidentiality how subjects’ personal data will be kept confidential persons who have access to the data. How long the period of data storage & whether data will be State whether subjects can request access to their personal info and study findings ESSENTIAL COMPONENTS OF A PROTOCOL

23. 3.15 Conflict of Interest Identify any consultative relationship that the investigators has with any entity related to the protocol. State how it is managed. 3.16 Publication Policy Must maintain subjects’ confidentiality 3.17 Termination of Study Relevant to RCT ESSENTIAL COMPONENTS OF A PROTOCOL

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25. And lastly the list of REFERENCE ESSENTIAL COMPONENTS OF A PROTOCOL

26. SUMMARY Participants have been informed of the essential elements in protocols that reviewers give attention to. Knowing that, participants should be able now to prepare protocols that will satisfy reviewers and facilitate approval.

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