Responding to an EMA Q&A

In July 2020, EMA released a Q&A to provide further insight on expectations on continuous oversight and frequency of investigators' signature collection on eCRF data reported to the sponsor.

Before filing a marketing authorization application, all eCRF data needs to be signed and dated. Principal investigators should sign off data related to SAE reporting, adjudication of important events and endpoint data, and DSMB review in a timely fashion. A timely review and sign-off of data entered directly into the CRF as source is particularly important in addition to the expectations mentioned above.

The eClinical forum recently had a set of webinars for sponsors to discuss their experiences and how they intend to meet EMA expectations. One example was the EMA requirement for there to be a direct connection between the signatures and the data being signed. To date, a significant number of systems do not yet adhere to the new EMA guidance on investigators signing data. Some clients struggle with software that either doesn't allow for signatures or has workarounds that do not fulfill requirements. Viedoc's PI signature process adheres to all the suggested recommendations of the EMA already today and in a way that makes doing so easy for all users.

Viedoc is created by people from the industry who understand the industry and users' needs. The developers at Viedoc think tirelessly through every step of the clinical trial process. This dedication to detail includes the signature process, where, for example, the role-based system ensures only the appropriate person can sign for a corresponding data set.

At Viedoc Technologies, we are continually pushing ourselves to ensure processes are compliant, easily adhered to, and perhaps most importantly, don't result in extra work for our users. If the users are not signing off because the system is too difficult to use, it can become impossible to maintain compliance.

The release of the EMA Q&A is a strong indication that timely signature requirements for principal investigators will be implemented relatively soon. Viedoc's vision has always been to set the standards for processes within clinical trials, and our modern platform ensures you will continue to be compliant now and in the future.

To find out more, please reach out to us today.

Enjoy your trial!