1. INTRODUCTION
1.1.1. This standard operating procedure (SOP) describes the policy and procedure in the performance of a Medical Record Audit (MRA) for the Office of Human Research Protection (OHRP) at the Medical College of Georgia (MCG) Health System. A MRA may be performed on the medical record of any research subject receiving a test article.
2. OBJECTIVE
2.1.1. The objective of this SOP is to describe the procedures used in performing the MRA.
3. SCOPE
3.1.1. This policy and procedure applies to all MRA’s performed by the OHRP.
4. PROCEDURES
4.1. The CTA will contact the Investigational Pharmacist via telephone or e-mail to request a list of randomly selected research study subject names including the study subjects’ medical record numbers. The Investigational Pharmacist will either fax or email the list to the CTA.
4.2. Once the CTA receives the list from the Investigational Pharmacist, the CTA will then access the electronic medical record (EMR) to locate the required documents. If the document(s) cannot be located in the EMR, then the CTA will contact the Health Information Management Services (HIMS) Technician and arrange a mutually convenient time for the CTA to review the hard copy medical record. In compliance with MCGHI policies, the audit of the research subjects’ hard copy medical record will take place in the HIMS area.
4.3. In compliance with federal regulations and institutional policies the medical records (e.g., EMR and hard copy) are assessed using the following standards:
4.3.1. Research Study Alert (RSA) or Study Alert located in the medical record. The RSA must be completed and submitted to HIMS for scanning into the EMR and filing in the research subject’s hard copy medical record. A RSA is required if more than one research related study visit is required and/or the research subject is hospitalized.
4.3.2. Signed and dated copy of the applicable consent document located in the research subject’s medical record as per current MCG Health System Policies and Procedures. the research informed consent documents are reviewed in accordance with OHRP SOP Informed Consent: Documentation of Process.
4.3.3. Documentation of the research subject’s voluntary participation in the progress notes prior to the initiation of any study specific procedure(s) per current OHRP SOPS.
4.3.4. Documentation of study visits reported as such in the progress reports per current OHRP SOPS.
4.3.5. Documentation of the research subject’s continuing informed consent at each and every study visit per current OHRP SOPS.
4.3.6. An electronic report is generated that addresses the standards found and standards not found. The original report is sent to the Principal Investigator (PI) via email. The PI will be requested to provide clarification including a plan of corrective action to eliminate the potential for this problem reoccurring in the future. The timeline given to the PI for responding is generally thirty (30) days from the date of the findings letter. A copy of the findings letter is sent to the Study Coordinator, Investigational Pharmacist, and a copy is provided to the IRB.
4.3.7. Prior to sending the MRA Findings Report to the PI, the CTA will contact the PI and/or Study Coordinator by phone or e-mail to explain the process behind the MRA. This contact provides an opportunity for the site to give feedback and to be given guidance as to how to respond to the MRA.
4.3.8. The results of a MRA may result in a “for cause” review of the study.
5. REFERENCES/DOCUMENTATION
- Medical College of Georgia Policies and Procedures
- MCG Health, Inc. Policies and Procedures
- http://hi.mcg.edu/aboutus/PDFPolicies/16_51.pdf
- http://hi.mcg.edu/aboutus/policies/PDFPolicies/16_51.pdf
- Human Assurance Committee Policies and Procedures
- International Conference on Harmonization Good Clinical Practices Guidelines
- Food and Drug Administration Title 21 Part 50 Regulations
- DHHS Office for Human Research Protections Regulations
- Clinical Research Standard Operating Procedures for MCG Health System
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Electronic Medical Records