The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication, GCP Questions, FDA Answers.
A site on my study has an electronic medical record (EMR) system but staff print copies of the records for the shadow chart for monitoring/auditing as the EMR system is not Part 11 compliant. The CRA has asked for the site to certify the copies and to look over the shoulder of the coordinator in order to confirm accuracy and completeness. However, the site will not allow the CRA to spot-check their EMR, stating that their SOP does not allow this.
Can you offer specific guidance on how the FDA views this site’s policy?
Monitors will want to at least spot-check the completeness of records at the source — the electronic database. How they view them is at your discretion, however. Either looking over the shoulder of a study staff member or having limited access is common.
The reason at least a spot-check is necessary is that the records can be selectively copied. If certified copies are used, they may not be complete records. The monitor is checking to ensure that study inclusion/exclusion criteria are met and that there are no concomitant issues that would preclude the individual’s participation in the study or confound the results.
In general, during an inspection, the FDA usually reviews original (source) records or certified copies of clinical trial records. For example, during an inspection of a clinical investigator (CI), the FDA investigator will evaluate the CI’s practices and procedures to determine compliance with applicable regulations. Quite often, CIs maintain copies of certain records in their study files, e.g., records from a hospital or other institution that must maintain the originals.
The FDA refers to these as shadow files. While it is acceptable to keep shadow files in the study records, should the FDA conduct a bioresearch monitoring inspection of the study in question, the FDA investigator will expect to review at least a portion of the original source documents for such shadow files to verify their authenticity, even if the copies in the shadow files are certified as authentic copies.
I suggest you discuss with the site how you can bridge the gap between the research site and the monitor so that EMRs can be viewed by you as well as the FDA, when appropriate.
A CRO is proposing to offer support to sites that are lacking resources by assigning its CRAs to conduct data entry at the site level.
Would this be considered a conflict of interest? Or is there a way to document that a CRA is at the site strictly to enter data that is backlogged?
While a CRO can employ monitors/CRAs for their own studies, such individuals are usually in departments that are independent from those that are responsible for the conduct of the study. We therefore recommend that the CRA not be someone who is participating in the conduct of the study.
You would want to avoid any appearance of conflict of interest as the conflict may lead to intentional or unintentional bias or errors in the clinical trial and may compromise the well-being of the human research subjects. The FDA would also recommend that the CRO have a specific SOP/policy that addresses this issue.
Additionally, the CRO operates on behalf of the trial sponsor and may have an interest in the sponsor (either through an equity interest or an interest in maintaining a business relationship with the sponsor). For example, the CRO has an interest in the timely completion of the clinical trial in order to meet the sponsor expectations and maintain the business relationship with the sponsor that would lead to more business for the CRO. This has the appearance of a conflict of interest.
You should check with your local and national laws and policies to see if there are any requirements related to conflict of interest and clinical trials.
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