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.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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