Archiving Clinical Trial Study Documentation PURPOSE This Standard Practice Guideline (SPG) describes the processes to ensure clinical trial related documentation is stored, retained, and is retrievable for reporting, auditing and regulatory purposes. (MANDATORY LANGUAGE) SCOPE This Standard Practice Guideline (SPG) applies to clinical trial study-related records that include, but are not limited to: patient research files, regulatory information, e-mail, telephone records, and all other correspondence. The process for archival of the electronic research data, programming, audit trails, and summarization data is not within the scope of this Standard Practice Guideline. (MANDATORY LANGUAGE) [Optional: Insert any additional details necessary to further define the scope of this SPG.] POLICY Good Clinical Practice (ICH GCP) This Standard Practice Guideline aligns with the Good Clinical Practice (ICH GCP) guidelines established by the International Council on Harmonization (ICH), Section 4.9.7: Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available for direct access all requested trial-related records. FDA Regulation(s) (if applicable) Per 21 Code of Federal Regulations Part 312.57: Record keeping and record retention require that a sponsor shall retain the records and reports required by this part for two years after a marketing application is approved. Per 21 Code of Federal Regulations Part 312.62 Investigator recordkeeping and record retention: An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not
Archiving Clinical Trial Study Documentation PURPOSE This Standard Practice Guideline (SPG) describes the processes to ensure clinical trial documentation is stored, retained, and is retrievable for reporting, auditing and regulatory purposes. (MANDATORY LANGUAGE) SCOPE This Standard Practice Guideline (SPG) applies to clinical trial study-related records that include, but are not limited to: patient research files, regulatory information, e-mail, telephone records, and all other correspondence. The process for archival of the electronic research data, related programming, audit trails, and summarization data is not within the scope of this Standard Practice Guideline. (MANDATORY LANGUAGE) [Optional: Insert any additional details necessary to further define the scope of this SPG.] POLICY Good Clinical Practice (ICH GCP) This Standard Practice Guideline aligns with the Good Clinical Practice (ICH GCP) guidelines established by the International Council on Harmonization (ICH), Section 4.9.7: Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available for direct access all requested trial-related records. FDA Regulation(s) (if applicable) Per 21 Code of Federal Regulations Part 312.57: Record keeping and record retention require that a sponsor shall retain the records and reports required by this part for two years after a marketing application is approved. Per 21 Code of Federal Regulations Part 312.62 Investigator recordkeeping and record retention: An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not