Site: <Enter site> Instructions: This is a sample Essential Documents Review Tool, based on ICH-GCP. Mark the appropriate box for each criterion listed. Any the QM Quarterly Review Tool. issues noted within “Comments” will be summarized in File the completed tool in the study files with other QM materials. YES NO N/A Document Criteria Comments √ √ √ Identification of the site, including name of PI, Study study location(s), Protocol Number and title, Identification etc. is present and correct on the study file. A current and IRB approved copy of the Protocol is on file. All previous versions of the Protocol are on file. Protocol Signed versions of the protocol signature page are available for each version of the Protocol. Any lapses have been documented properly. A current and IRB approved copy of the Consent Document is on file. All previous versions of the Consent Document Consent are on file. Document(s) Any lapses have been documented properly. Local All local, state, and/or special authorizations Regulatory related to the protocol are maintained and Approvals Federal Wide Current Federal Wide Assurance and IRB Assurances Registration documents for governing regulatory bodies (e.g., IRB), issued from (FWA)
Site: <Enter site> Instructions: This is a sample Essential Documents Review Tool, based on ICH-GCP. Mark the appropriate box for each criterion listed. Any issues noted within “Comments” will be summarized in the QM Quarterly Review Tool. File the completed tool in the study files with other QM materials. Document Criteria YES √ NO √ N/A √ Comments Study Identification Identification of the site, including name of PI, study location(s), Protocol Number and title, etc. is present and correct on the study file. Protocol A current and IRB approved copy of the Protocol is on file. All previous versions of the Protocol are on file. Signed versions of the protocol signature page are available for each version of the Protocol. Any lapses have been documented properly. Consent Document(s) A current and IRB approved copy of the Consent Document is on file. All previous versions of the Consent Document are on file. Any lapses have been documented properly. Local Regulatory Approvals All local, state, and/or special authorizations related to the protocol are maintained and Federal Wide Assurances (FWA) Current Federal Wide Assurance and IRB Registration documents for governing regulatory bodies (e.g., IRB), issued from
qm-essential-documents-review-tool.docx