By admin We wish to print medical records from Electronic Health Record system that does not automatically apply a date and our name. Can we use a stamp with institution name and date to create certified copy as source records for clinical trials?
Dr Alka Nadkarni
There is no specific regulatory guidance on this issue of using a stamp for certified copy. It would be desirable to develop standard operating procedures (SOPs) for this process. If you wish to use a signature stamp for this purpose, the SOPs should address any necessary controls over the stamp. The SOP should describe (1) who is authorized to use the stamp, (2) where the stamp is stored and (3) how access to the stamp is controlled, (4) the type(s) of correspondence on which it may be used, and (5) the circumstances under which this procedure would be employed. Your site should follow this SOPs that you develop. This practice would be considered in compliance with good clinical practice.
Do the FDA GCP inspection observations have the equal severity? How many violations will lead to a warning letter?
Dr Girish Mehta
The FDA GCP inspection observations are captured in Establishment Inspection Report (EIR) classifications as follows:
• NAI – No Action Indicated — No objectionable conditions or practices were found during an inspection (or the objectionable conditions found do not justify further regulatory action)
• VAI – Voluntary Action Indicated — Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
• OAI – Official Action Indicated – Regulatory and/or administrative actions will be recommended.
Warning letters are only issued after FDA has reviewed all information pertinent to the findings of an inspection. This information includes the 483, inspection report (EIR) and any other information such as a response to the 483. Warning letters are reserved for the more significant cases of noncompliance where the final compliance classification is OAI. Many inspections result in a 483 but do not result in a warning letter.
An OAI recommendation is appropriate when regulatory violation(s) uncovered is/are significant/serious and/or numerous, and the scope, severity, or pattern of violations(s) are numerous.
The 483 would not be used alone in judging GCP compliance. The 483 is a list of the inspector’s observations which in the inspector’s judgment represent deviations from the regulations which are significant. The decision as to whether a 483 observation is indeed a regulatory deviation is an agency decision made after review of all the facts as reported and documented in the EIR and from other sources such as correspondence from the inspected party. After each inspection, the FDA Center, with responsibility for the inspection, will issue a post inspection correspondence which communicates the agency’s final decision on the compliance status of the site inspected. The Center will assign a final compliance classification as either OAI, VAI, or NAI.
Warning letters are a form of post inspection correspondence, but they are only sent to the investigators, or the sponsors that are seriously non-compliant.
Our company who procures human specimens (blood, tissue, urine, apheresis, etc) and provides them to researchers in oncology, haematology and immunology. The samples are collected after obtaining ethics committee approval of protocols and informed consent of each donor. How do claim GCP certified status?
Dr Shashwat Mukherjee
Generally, the regulatory authorities would consider a firm or company GCP compliant if they follow GCP practices or have taken GCP training. This has nothing to do with a firm being inspected (audited) by regulatory authorities.
The authorities would expect documentation of qualifications, training and experience of the investigator and the sponsor team. The study team should be knowledgeable about applicable regulations, good clinical practice, human participant protection, data integrity, record keeping, and specific areas essential to the conduct of a particular study.