Validating electronic source data clinical trials

Rated 4.60/5 based on 552 customer reviews

We strictly adhere to FDA and EMA guidance and can provide regulatory and clinical data consultancy for Sponsors looking to implement a risk-based approach.We are also able to support Sponsors with the validation of electronic systems for use in clinical investigations.The FDA has recently issued a draft guidance on “Use of electronic records and electronic signatures in clinical investigations under 21 CFR Part 11 – Questions and Answers”.

Implementing the part 11 rule on mobile phones is not an easy task because the rule doesn’t specifically talk about that: the FDA clarifies many different situations with this simple approach of Q&A and its intention to push it forward is now even clearer.The extent of validation should be tailored to the nature of the system and its intended use.It is worth mentioning that even if using a cloud system validated by the vendor, the system should anyhow be validated by the company utilizing the system, to ensure compliance with company processes and procedures.These two Q&A are particularly interesting as mobile technology is becoming more and more widely used in clinical investigations to collect patient’s diary data, questionnaires, and daily drug compliance which are often primary or secondary endpoints of a clinical study.It is important to clarify with the sponsor and investigator what is considered source data and include it the clinical protocol.

Leave a Reply