Below are some pointers for preparing for an inspection and audit.

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)