The clinical records management community is currently enjoying an interesting debate regarding the need for interoperability standards for electronic trial master file (eTMF) content. The need for organizations to efficiently exchange documents and metadata between systems is becoming increasingly critical, especially so when studies are outsourced to a CRO who uses a different eTMF solution to the one being used by the trial sponsor. The requirement also comes fro mthe exchange of content with the investigator site, And so far, the debate has been about exchanging documents. Not for much longer!
The Indian Ministry of Health & Family Welfare Food & Drug Administration (New Delhi) has recently issued an order that mandates the collection of certain trial records in audio-visual format. Order GCP/20/SC/Clin./2013 DCGI (19-NOV-2013) requires that in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed content process, including the procedure of providing information to the subject and his/her understanding of such consent, is required to be done, whilst adhering to the principles of confidentiality. The audio-visual recording will form part of the trial record at the investigator site (the investigator site file) and should be preserved. This new order is applicable with immediate effect to any new subjects to be enrolled in all clinical trials in India, including global clinical trials (i.e. where the sponsor is located outside India).
Firstly, let’s touch on the subject of confidentiality and then we’ll move on to records management issues! It will be interesting to see how an audio-visual recording of an informed consent process can be made such that the study monitor can view evidence of the informed consent but without compromisng subject confidentiality.
So let’s think about the records management issues. How will the recording be made? Presumably, with smartphones and digital cameras so prevalent, the recording will be captured digitally. What format will the files take? How will they be transferred from the recording device? What storage medium will they be transferred to that is suitable for archiving? Will the recording and transfer process be validated? What will happen in poorer, rural areas of India where digital capture might not be possible? Will recordings be made on video tape….. what format?
I think many of these questions can be answered with relative ease but they need to be addressed by the sponsor when the study protocol is being developed. Responses to these questions should not be made by individual investigator sites in reactive mode to avoid inconsistent, non-validated processes being adopted.
About Rammell Consulting: We are a specialist records management consulting company, providing a range of consultancy, training and education services to the life sciences/healthcare sector. Topics that we advise on include electronic archiving and digital preservation. Please refer to our website for further information.