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Maintaining a Protocol

While putting together a good protocol and getting approval from the IRB-SBS is an excellent first step towards protecting research participants, the real work happens while you are conducting the study. Compliance with federal regulations does not end when you receive approval or exemption from the IRB; instead, compliance happens every time you provide a participant the consent form, collect data from a participant, and make a decision about how to use that data.  Compliance is on-going until the study closes and even beyond that if the data are used in future studies.  Likewise, your relationship with the IRB-SBS is also on-going as we help you to conduct your compliant study. The purpose of this section is to outline your requirements for maintaining an IRB compliant study.

Section Topics

Record Keeping and Requesting Digital Copies
Protocol Modifications

>>Updating Section B “Protocol Information”
>>Submitting the Modification Form
>>Modification Review Procedures
Undesirable Research Events
>>Definitions
>>Reporting Requirements
>>Reporting Procedure
Continuing Review
>>Submitting a Continuation Request
>>Continuation Review Process
Study Closure

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