Protocol Guidelines

The Protocol Writing guidelines listed below are adapted from the World Health Organization to help you in writing a complete research protocol.  These Guidelines are not meant to be exhaustive.  For example, if the study is a drug study, you should indicate whether an IND has been obtained, or if the drug is exempt from IND requirements [21 CFR 312.2(b)].

Likewise, if the study is a device study, you should indicate whether the device poses a significant risk (SR) or non-significant risk (NSR) to participants, or if the research use of the device is exempt from IDE regulations [21 CFR 812.2(c)].

 

1.   Project Summary

 

Like the abstract of a research paper, the project summary, should be brief and at the most a page long.  The Project Summary should summarize all the central elements of the protocol, for example the rationale, objectives, methods, populations, time frame, and expected outcomes. It should be written in lay language so that the “average person” can understand it.

 

2.   General Information

 

  • Protocol title, protocol identifying number (if any), and date.
  • Name and address of the sponsor/funder.
  • Name and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of each.
  • Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the research

 

3.   Rationale & Background Information (Introduction)

 

The Rationale specifies the reasons for conducting the research in light of current knowledge. It should include a well-documented statement of the need/problem that is the basis of the project, the cause of this problem and its possible solutions. It is the equivalent to the introduction in a research paper and it puts the proposal in context.

This section should answer the question of why and what: why the research needs to be done and what will be its relevance. The magnitude, frequency, affected geographical areas, ethnic and gender considerations, (and such) of the problem should be followed by a brief description of the most relevant studies published on the subject.

 

4.   Study goals and objectives

 

Goals are broad statements of what the proposal hopes to accomplish. They create a setting for the proposal. Specific objectives are statements of the research question(s). Objectives should be simple (not complex), specific (not vague), and stated in advance (not after the research is done). After statement of the primary objective, secondary objectives may be mentioned.

 

5.   Study design

 

The scientific integrity of the study and the credibility of the study data depend substantially on the study design and methodology. The design of the study should include information on the type of study (drug, device, or behavioral), the research population, and who can take part (e.g. inclusion and exclusion criteria, withdrawal criteria etc.), and the expected duration of the study

Note: The same study can be described in several ways, and as complete a description of the study as possible should be provided. For example, a study may be described as being a basic science research, epidemiologic or social science research, it may also be described as observational or interventional; if observational, it may be either descriptive or analytic, if analytic it could either be cross-sectional or longitudinal etc. 

 

6.   Methodology

 

The methodology section is one of the most important parts of the protocol. This section should include detailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made, laboratory investigations to be done, etc. If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly defined.

Interventions should be described in detail, including a description of the drug/device/vaccine that is being tested. Interventions could also be in the realm of social sciences for example providing training or information to groups of individuals.
Procedures could be biomedical (collection of blood or sputum samples to develop a diagnostic test), or in the realm of social sciences (doing a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participant's environment, etc.).

Standardized and/or documented procedures/techniques should be described and bibliographic references, if not provided earlier should be provided. Instruments which are to be used to collect information (questionnaires, observation recording forms, case report forms, etc.) must also be provided.

In the case of a randomized controlled trial, additional information on the process of randomization and blinding, description of stopping rules for individuals, for part of the study or entire study, the procedures and conditions for breaking the codes, etc. should also be described.

A graphic outline of the study design and procedures using a flow chart or table and timeline of procedures should be provided.

 

7.   Risk/Benefit Considerations

 

The safety of research participants is foremost. The balance of the risk/benefit ratio must be considered and safety aspects of the research should always be kept in mind.  The information provided in the protocol should detail how the safety of research participants will be ensured. This can include procedures for recording and reporting adverse events and their follow-up, for example, in addition to the use of a Data Safety Monitoring Board (DSMB). It is useful to remember that even administering a research questionnaire can have adverse effects on individuals.

 

8.   Follow-up

 

The research protocol must give a clear indication of what follow up will be provided to the research participants and for how long. This may include a follow up visit, especially for adverse events, even after data collection for the research study is completed.

 

9.   Data management, data security, and statistical analysis

 

The protocol should provide information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification. The protocol should also provide a detailed plan for data security.  The statistical methods proposed to be used for the analysis of data should be clearly outlined, including reasons for the sample size selected, power of the study, level of significance to be used, procedures for accounting for any missing or spurious data etc. For projects involving qualitative approaches, specify in sufficient detail how the data will be analyzed.

 

10.   Monitoring

 

This section of the protocol should describe the quality control and quality assurance system for the conduct of the study, including GCP, follow up by clinical monitors, DSMB, data management etc.

 

11.   Expected Outcomes

 

The protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health policies.

 

12.   Study Duration

 

The protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be undertaken.

 

13.   Problems anticipated

 

This section should discuss the difficulties that the investigators anticipate in successfully completing the project within the time frame stipulated. It should also offer possible solutions to deal with these difficulties.

 

14.   Roles and Responsibilities

 

This section should describe the role and responsibility of each member of the team

 

15.   Ethics and Obtaining/Documenting Informed Consent

 

A statement should be made that the clinical study is being conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonization guidelines on GCPs, and applicable local regulatory requirements and laws. 
This section will also outline subject confidentiality and rights and state that it is the responsibility of the principal investigator, or person designated by the investigator, to obtain a freely signed informed consent from each subject, or from the subject’s Legally Authorized Representative (LAR), prior to the initiation of study procedures. 

The protocol must also have copies of the informed consent document.  If the research involves more than one group of individuals, for example adults and children, a separate specifically tailored informed consent document must be included for each group. This ensures that each group of participants will get the information they need to make an informed decision. 
In addition to the consent documents, you must describe the means that will be taken to determine whether a participant or participant’s LAR has clearly understood the information presented in the Informed Consent Document(s) - in other words, a description of the plan for assessing the participant’s comprehension.

Please email us if you would like a copy of the PrimeIRB Protocol Template.