Source data is being collected utilizing electronic methods. This is seen at a site (for example via electronic medical records) but also subjects are being asked to provide data electronically. This could include an interactive voice/web response system or even utilizing a tablet or handheld device. This process raises several questions. Does the Investigator have access to this source data? If yes, is there a documented review? If no, this could be the first indication that the Investigator is not maintaining a complete medical history. Will this data be provided to the Investigator at the end of the trial? This source data could be over looked as part of the medical history; however, it could include endpoint data and is source data. During recent audits, it was described that data was collected on a device maintained at the site. The subject had their own user name and password, logged in, and completed questionnaires. The Investigator also had their own user name and password. I was provided read only access to the website where the data (including log in information) was available for review. The site also has access to the website. When the site staff was questioned regarding receiving the data at the end of the study, their response was that they were unsure. They assumed that since they receive their eCRF data, they will also receive the data from the device/website. If Investigators do not maintain this source data, the FDA or other Health Authority will cite them for ‘Failure to maintain complete records’ (21CFR 312.62(b)) and the related Sponsor for ‘Failure to provide the Investigator with the information they need to conduct an investigation properly’ (21CFR 312.50). Investigators and Sponsors need to remember the importance of obtaining and maintaining all electronic data to meet all regulatory requirements.
- ADAMAS has all your global QA needs covered. Meet us at DIA 2018 this April and let us show you the ADAMAS advantage.
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- India: PV Guidance Document
- ADAMAS at RQA’s 5th Global QA Conference in Edinburgh, UK 1–3 November 2017 Stand#14
- India: EC Accreditation Process: Highlights