Choosing and Using a Protocol Template
Protocols for Multi-center Research:
It is important to not waste time and effort by creating a CHOP-specific protocol for a multi-center research study. The CHOP IRB will not accept it. The IRB will only accept a single document as the study protocol and this must be the overall study protocol. An addendum may be submitted that supplements the protocol to cover issues related to study execution here at CHOP. Some examples include recruitment issues, discussion of standard of care here at CHOP or a risk - benefit discussion. However, most of this information will already be adequately covered in the eIRB application.
The IRB provides several protocol templates on this page. They follow the format of typical NIH and industry multicenter protocols. The Intervention template is ICH GCP compliant. None of the templates is likely to be perfect for a given study without some modification. It is expected that the investigator will adapt the template to suit their needs. Sections that are not applicable should be deleted and if necessary, additional sections may need to be added.
The most common error is to use the Descriptive template instead of the Observational template for retrospective cohort studies. The descriptive protocol is intended for simple, descriptive research studies, particularly those limited to review of existing (retrospective) medical records. Do not use this protocol for more complex studies such as cohort or case-control designs.
Try to limit the amount of repetition across the various sections of the protocol to make it easier to ensure consistency.
|Descriptive Study Template:
This template should only be used for for studies limited to (1) the use of existing data or specimens, (2) where the only study procedure is a retrospective chart review or use of existing biological samples and (3) where the analysis plan is limited to purely descriptive summary statistics. This template should not be used for observational study designs (cohort, case-control, cross-sectional); the Observational template should be used for these designs.
|Observational Study Template:
This template is intended for observational studies - those without an active study intervention - including cohort, case-control, cross-sectional and prospective descriptive study designs. Observational studies are those where the assignment of subjects to groups is determined by nature, serendipity, the subject, or the subjects' clinicians rather than by the investigator. Although group assignment is not made the investigator there can still be considerable risk from the procedures for monitoring outcome (e.g. MRI with sedation, LP for CSF or bone marrow, etc.).
|Intervention Study Template (clinical trials):
This template is intended to be used for clinical trials. Clinical trials are intended in their broadest sense and means any study design that involves an intervention regardless of the nature of that intervention (drug, biologic, device or other treatment strategy) or method of treatment assignment (non-random process or randomization). The format of this template closely follows the International Conference on Harmonisation Guidance on Good Clinical Practice Requirements. The current version includes an Abstract, a Safety Management plan for minimal risk studies and some additional guidance and instructions.
| Signature Page:
When the overall PI for a multi-center study is from CHOP, the protocol should have a signature page to document that the other site investigators agree to conduct the research in accordance with the federal regulations. This example signature page may be adapted and modified as needed. It should be inserted to follow the title page in the protocol.
This template is intended for protocols that don't involve research per se other than to collect data or biospecimens for research in the future. When the information collected is limited to data, this is considered a Registry and collections of biospecimens with or without accompanying data are considered a Repository.
|Protocol/Treatment Plan Template for Single Patient Treatment IND (expanded access)
This Protocol/Treatment Plan is an example, designed specifically for Single Patient Expanded Access or Emergency Use. It is assumed that this template will be used as a starting point and might need modifications to adapt to the single patient to be treated. The example assumes the use of a drug. The actual content will vary depending on the nature of the investigational agent and whether procedures are done as part of the clinical investigation or clinical care.
|Protocol/Treatment Plan for Single Patient IND||8-11-2020|
Additional Resources for Writing Protocols
The IRB's webpages on Protocols and Study Design have more detailed explanations to help guide the writing of a protocol. The Study Designs page includes numerous basic journal articles linked to PubMed, introductory books on clinical epidemiology and clinical trials and links to consensus reporting guidelines for clinical trials, observational studies and diagnostic studies.
Writing a Protocol has a section-by-section explanation completing the Intervention Protocol Template. These examples are applicable to the other templates as well.
Johns Hopkins provides open course ware (JHSPH Open courseware) including both Fundamentals of Epidemilogy Il and Fundamentals of Epidemilogy Il, both originally used in 2008. Together these courses include 22 of the original 24 modules related to epidemiology and biostatiistics. The lecture slides and lists of references are available for free.
OHRP IRB Guidebook: Chapter IV - Considerations of Research Design: This chapter of the IRB Guidebook provides an overview of a variety of research designs. It puts the information into context for IRBs to identify issues related to the various types of study designs. The IRB Guidebook was released in 1993 and while much of the regulatory material is out of date (it is only maintained in OHRP's archive), the chapter on Research Design is still relevant for investigators and IRBs.