In This Section
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.
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.
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.