Continuation from “What Is The Difference Between NHG RQM Study Reviews & HSA Inspections”(Part 1, December 2013 issue). Below are some pointers for preparing for an inspection and audit. 4. Investigational Product (IP) 1. Source Documents • Ensure all source documents are documented clearly • Ensure IP are stored in a secured place and the temperature logs are available and complete. and filed in appropriate medical records, pharmacy • Ensure all IP shipment and dispensing records are folders or other research folders. documented and tallies with the IP accountability • Ensure medical records are easily retrievable and be log. available on the inspection/audit date. • Ensure only authorised staff are allowed to prescribe 2. Informed Consent Forms (ICF), Documentation & and dispense IP. Processes • Ensure IP is used for study subjects only. • Ensure that All original ICFs are easily accessible. 5. Biological Samples – if applicable • Check that the ICFs used are the versions approved • Ensure biological samples are identifiable or coded by the DSRB. (according to study protocol and DSRB application • Ensure that consent were obtained from each form). subject participating in the study prior to performing • Ensure biological sample storage and/or shipping any trial related procedures and that the subject logs are maintained. personally signed and dated the ICF. • Ensure biological sample temperature logs are • Ensure that a patient identification list is available. maintained. 3. Study File/ Investigator File (IF) • Ensure temperature log for freezer is available if it is Ensure all documents are updated in a timely manner in used for storage of biological sample (i.e. blood/ the IF: tissue samples). • All versions of DSRB approved study protocol and • Ensure equipment are well maintained, annually investigator/ protocol signatory pages and calibrated and maintenance log is available. Investigator Brochures (for Investigational Products). 6. Study Team –During The Interview • All versions of DSRB approved English Main ICF, ICF • Ensure all relevant people are present for the addendums and translated ICF with certificate of opening meeting and available for the interview. translation; original signed ICFs. • Listen carefully to the inspector/auditor, and take • All DSRB/regulatory approvals and correspondences. notes of his/her comments (those may be part of the • Study Team members’ Curriculum Vitae (CV), internal report). Ask for clarification if you do not licences, training logs and delegation log. understand what is asked. • Ensure all study documents are kept in a secure • Answer only if you really know; Answer with facts place. and supporting documents. Note: Please refer to SGGCP section 8 for list of the • Have personnel available who may assist in the essential documents for the conduct of a clinical trial. response to issues raised during the inspection. • Remain Calm. References http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials/guidelines/gcp_compliance_inspection.html Singapore Good Guideline for Good Clinical Practice (SGGCP) 4.6: Investigational Product Singapore Good Guideline for Good Clinical Practice (SGGCP) 4.8: Informed Consent of Trial Subjects Singapore Good Guideline for Good Clinical Practice (SGGCP) 8: Essential Documents For The Conduct of Clinical Trial NHG Investigator Manual (2nd Edition): Chapter 9.0 – Preparing for Audits https://www.research.nhg.com.sg/wps/wcm/connect/romp/nhgromp/hspp/rqframework/study+reviews+audits Article Contributed By: Ms Xu Xiaoying, Research Nurse Supervisor, Johns Hopkins Singapore International Medical Center Edited By: NHG-RDO Proudly brought to you by: Clinical Research Coordinator Society (CRCS) ([email protected]) January 2014 How To Prepare For RQM Study Reviews and HSA Inspection? (Part 2)