SOP for CRA Limits on Viewing Source Documents

Purpose:
To ensure that visiting CRA’s treat all person private information contained in the Source Documents (otherwise know as DSI Clinic Records) with the proper HIPAA restrictions so as not to allow more information than absolutely necessary to perform SDV (Source Document Verification) to be viewed as per GCP Guidelines. That is, monitors are required to look at only that information that is needed to perform their job. Furthermore, should they view information that is not needed they will hold confidentiality as if they were an employee of DSI.

Scope:
Confirming that accurate and reliable information has been reported by the investigator to the sponsor during clinical trials is a fundamental requirement of good clinical practice (GCP), and there can be significant implications if this is not undertaken appropriately. HIPAA further defines one should use as little of the patient/research subject volunteers PHI (Personal Health Information) as necessary to do your job.

Responsibility:
The responsibilities of both the investigational team and the sponsor in SDV (Source Data Verification) must be made clear at the outset of the trial. Considerations such as access to data and confidentiality must be fully addressed, so that there are no misunderstandings or surprises when SDV is undertaken. Records of what was done and found, including an evaluation of the findings, must be made, in the same way as for any other aspect of the trial. There must also be a recognition that SDV really adds value to a trial, but this can only be effectively achieved if everyone fully appreciates the objectives associated with SDV. There will be PHI that is not relevant to the monitoring of this trial. An example of this may be some information regarding a competitors trial present in the medical records DSI is using as Source Documents. It is your responsibility to note this is not needed and you should remain as confidential about what you may have seen as you expect other visiting CRA’s to be with your data.

The Medical Records (Source Documents) at DSI:
There is a requirement for all physicians investigating or treating patients to document all relevant findings and changes to current therapy in their medicla records. Clinical trials are undertaken to investigate/test clinical hypotheses in a systematic way. For every patient/research subject volunteer participating in such trials, all findings and changes to current therapy need to be documented in the same way as if they were done as part of everyday clinical practice-outside a clinical trial. This data will be stored in our Source Documents (Clinic chart).

Confidentiality:
To maintain the propriatary secret sponsor nformation regarding their experimental protocol, DSI uses a “Shadow Chart.” That is, the ICF and other study specific information will be placed on the Shadow Chart and later filed with the regulatory binder and not the Clinic Chart. This will lessen the chance that this information will be viewed by those who are not supposed to see it. This creates the problem of SDV (Source Data Verification) to ensure what is in the Shadow Chart is also true and correct from the Source Documents in DSI’s Clinic Chart. We are routinely asked if CRA’s will have full unrestricted access to the Clinic Charts to perform SDV. It is the purpose of this SOP to make the visiting CRA acutely aware of the HIPAA regulation rerarding PHI (Personal Health Information) and the need to only use that PHI that is necessary to do your job. Should you encounter PHI that DSI found necessary to record to practice good clinical medicine that might be propritary information from one of your compititors, you should act with the same level of confidentiality as if you were an employee of DSI and not record or share this information with anyone else.

Visiting Monitors Responsibilities of SDV
ICH GCP identifies responsibilities for the SDV process. The investigator: "should ensure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor in the CRFs and in all required reports." The monitor's responsibility is to ensure that: "the reported trial data are accurate, complete, and verifiable from source documents." HIPAA guidelines teach us it is alright for the CRA to view a “footprint” that the research subject volunteer participated in another trial. The Shadow Chart lessens the amount of information that is viewable. This SOP helps protect the propriatary nature of the trial by reminding the CRA that they are abliged to use only that data neede to perfor their job and if they view extra data that they promise to hold it as confidential as if they were a DSI employee and signed the CDA (Confidential Disclosure Agreement).

CRA’s signature below agreeing to follow HIPAA and ICH-GCP confidentiality points as outlined above.