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Internal Quality reviews Research Administration SOP No: R-Reg-104 SOP Title: Internal Quality Reviews
5.2
3. Review the regulatory binder for the site activation letter from the sponsor.
Selection Process
It is the goal of every study team to be “audit ready”. In line with this expectation, it is strongly recommended that an internal quality review or review be completed for each new subject enrolled. For new studies, it is recommended that 100% of the newly acquired data for the screening visit be reviewed. Furthermore, it is encouraged that an internal quality review be completed upon inheriting an existing study from another coordinator and before the study is closed and prepared for long term storage. Subsequent internal quality reviews for quality review may be done using a random selection process.
A random selection process should take into account the number of anticipated quality reviews based on study design complexity, phase of development, investigator’s experience, previous site compliance, and rate of subject enrollment. Each study coordinator should discuss what the appropriate expectations for review should be in order to best support the study. For example, it is recommended that all studies seeking marketing approval for FDA have an essential quality review completed annually, whereas all exempt and expedited studies may have an essential quality review completed before the study closes and an abbreviated review periodically, or contingent upon enrollment rate, or study transition to another team member.
For studies seeking marketing approval for FDA:
• Complete 100% review of the Screening Visit for the first subject enrolled
• Complete an essential quality review annually, or with a study transition
• In addition to the above: for best practices, a random selection process is advised to complete a full review of a selected number of subjects for a given study based upon the number of subjects enrolled
Number of Subjects Enrolled
Regulatory Review
Subject Review
0-1
Full Regulatory
Full Subject Review
2-5
Full Regulatory
2 subjects (Randomization/ Every Dosing Visit; and every third follow-up visit)
6-10
Full Regulatory
3 subjects (Randomization/1st Dosing Visit; and every third follow-up visit)
11 or greater
Full Regulatory
4 subjects (Randomization/1st Dosing Visit; and every fifth follow-up visit)
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