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The following are the documents that are
reviewed during the compliance review:
- Correspondence with the IRB
- Correspondence with any other institutional oversight committees, such as GCRC, AURPAC, etc. (if applicable)
- Regulatory documents and correspondence with the Federal authorities and/or sponsor (if applicable)
- Original copies of the signed and dated consent forms for each subject or a sample of subjects
- Written documentation of the consent process for each subject
- Subject study records and any source documents (e.g., hospital and clinic charts; x-rays,
scans, and other special studies required by protocol; and operative, pathology and radiotherapy reports)
- Adherence to protocol
- Serious and/or Unexpected Adverse Event documentation and copies of required reports to the IRB, and to the
federal authorities (if applicable)
- Drug receipt, storage, labeling, and dispensing log (if applicable)
- Research records (e.g., screening log, subject enrollment log, exclusion log and case report forms)
- Lab certification, normal laboratory values, and staff training or certification documentation (as applicable)
- Data entered for analysis (if applicable)
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