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
1. Study title - must match the objective(s)
2. Protocol no., version no. & date - up to you
3. Name & institution of PI
4. Name & institution of Co-I(s)
5. Name & address of Sponsor - grant / self-funding
6. Study site(s)

5. Example

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

7. Example

8. CONTENTS
1. Background and Significance
 Find 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. 2. Objective
 General objective
 Specific objective(s)
ESSENTIAL COMPONENTS OF A
PROTOCOL
Example

10. 3. Methodology
3.1 Study Type and Design
 Type - 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.)
 Interventional study – describe the intervention used
If relevant, include:
 Number of study groups, ratio of subjects in control &
treatment group
 Specify randomization or blinding if relevant
 Types, quantity & frequency of biospecimens collected
 Describe the instruments used i.e questionnaires
(validated?), interviewers (well-trained?)
 Flow chart (more complex studies)
ESSENTIAL COMPONENTS OF A
PROTOCOL

12. Example

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

14. Example

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

16. Example

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

18. Example

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: There 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

24. Example

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.

27. design™