The new article describes the aspects related to the use of electronic form in certain aspects associated with clinical trials.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to electronic systems, electronic records, and electronic signatures in clinical investigations. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance. Once finalized, the document will represent the current thinking of the authority on the matter, hence, it could be subject to subsequent changes implemented from time to time, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. 

Regulatory Background

The scope of the present draft guidance covers the aspects related to the use of electronic systems, electronic records, and electronic signatures in the context of clinical investigations of medical and some other categories of products. In particular, the guidance outlines the regulatory requirements to be followed by the parties involved and also provides additional recommendations to be considered in this respect.

First of all, the authority states that in accordance with provisions of regulation 21 CFR part 11, electronic systems, electronic records, and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 

The initial requirements related to the use of the electronic form for documentation used in the context of medical devices and clinical trials associated thereto has been adopted by the FDA earlier in 1997. As it was mentioned before, these records and corresponding signatures are acceptable provided specific criteria are met. The authority acknowledges the rapid technological development taking place nowadays, and takes the steps necessary to ensure the regulations reflect the current state-of-the-art. For this purpose, the authority implements new rules and makes changes to the existing ones. The latest revision took place in 2003, so now the authority is considering the amendments to be implemented in order to accommodate the technological development taking place since that time. The authority acknowledges that the actual capabilities of the technologies used have improved significantly, creating new opportunities for electronic record-keeping.

Apart from that, the document also provides additional recommendations to be considered by the parties involved with respect to validation intended to ensure the authenticity, integrity, and confidentiality of electronic data and records for clinical investigations during their creation, modification, maintenance, archival, retrieval, and transmission. The document also covers the matters related to the requirements for information technology (IT) services in the context of the use of digital health technology (DHT).

The draft guidance is structured as a questions-and-answers document where the authority provides answers to the most important questions raised by the industry with respect to the use of electronic format for documentation, execution, and record-keeping. These answers are provided in the context of Good Clinical Practice (GCP), which stands for an international ethical and scientific standard for designing, conducting, recording, and reporting clinical investigations that involve the participation of human or animal subjects. Continued compliance with the respective regulations provides additional assurance of safety and protection for the patients involved (study subjects). As a part of it, electronic records could be used to ensure the trustworthiness and reliability of the data stored.

Electronic Records: Key Points

First of all, the authority outlines the main aspects related to the use of electronic records. Recommendations and clarifications provided in the guidance are applicable to: 

  • Records needed for FDA to reconstruct a clinical investigation that are maintained and archived under predicate rules in electronic format in place of paper format or where the electronic record is relied on to perform regulated activities;
  • Records submitted to FDA in electronic format under predicate rules, even if such records are not specifically identified in FDA regulations. 

In this respect, the authority emphasizes the following:

  • Requirements set forth by regulation 21 CFR part 11 also apply to electronic records from real-world data (RWD) sources used in the course of clinical trials, even if they are not explicitly mentioned in the respective provisions. 
  • If a clinical investigation takes place on a site based abroad, the aforementioned requirements related to electronic records would still apply. 
  • Any records containing the data used to support the claims made with respect to a medical device in question should be credible and accurate. 
  • If a sponsor, clinical investigator, or other regulated entity intends to maintain and retain a copy of an electronic record required for the clinical investigation in place of an original paper or original record, the copy maintained and retained should be a certified copy. 

In summary, the present draft guidance issued by the FDA provides an overview of the existing regulatory requirements in the sphere of electronic records. The document highlights the key points to be considered by study sponsors and other parties involved in order to ensure the trustworthiness and reliability of the records stored in electronic format in cases when such records contain the data used to support the claims associated with a medical device subject to investigation.




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