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NL initiative to assess electronic health record systems using eCF eSRA tool
The Dutch Clinical Trial Foundation (DCTF) has endorsed an EHR working group committed to the implementation of one uniform tool for the validation of electronic health record (EHR) systems used at clinical research sites within the Netherlands. The group consists of representatives from several pharmaceutical companies, CROs and hospitals, and is chaired by Martijn Griep, Johnson & Johnson Regional QC Manager, coordinated by Dana De Beuckelaer-Dournez from the University of Antwerp.
After considerable research and discussion with national stakeholders, the working group has chosen to use the eSRA (eSource-Readiness Assessment) program to harmonize the review of the EHR systems and to prove compliance against appropriate clinical research regulations and guidances. eSRA is provided for free by the eClinical Forum (a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry).This tool is intended to make the clinical research process more efficient, while furthering the use of EHR records for clinical research. Clinical research sites are often asked by their clinical trial sponsors to complete questionnaires regarding their EHR system. With each sponsor having its own questionnaire, completing a different form for each sponsor can be very time consuming. By using the eSRA system to complete a standard form, they can do it once and provide it to all their sponsors. And, since eSRA is based on the EMA and FDA regulations, the resulting report is appropriate to share with regulators.
The EHR working group started a pilot in three big hospitals to assess their systems using eSRA. Ellen Rusch, scientific member Scientific Institution, Martini Hospital Groningen and one of the members of the working group, was the first to complete the process.. She reported that the website that hosts the eSRA system was easy to use without any training. She worked with her IT support staff, and together they were able to complete the assessment in only 30 minutes! “We do about 50-80 trials each year and we are receiving a new sponsor questionnaire to complete about every 2 weeks. Each sponsor has their own form with questions worded differently, so it is very time consuming to work through each questionnaire. Each sponsor form takes an hour or more to read the new form, determine the answers and file the form. Then we must wait for the sponsor to review the form and sometimes re-work if there are any errors, etc. Some pharma-provided forms can be rather long, even though they all seem to ask the same questions, just in a different format each time. By doing the eSRA assessment once, knowing that it has been completed correctly, and providing the resulting report to the sponsors, we will save a lot of time. In addition, by registering for notifications, the eSRA system will notify us if any clinical research regulations have changed that we should be aware of.”
Martijn Griep, J&J, says “The completion of an eSRA assessment by the Martini Hospital is an important first step towards the registration of more sites and towards gaining the interest of large EHR system vendors to cooperate. By having the EHR vendors complete a pre-assessment of their systems, eSRA can be even more efficient, as these vendor assessments will be used as a resource for our clinical research sites when they complete their site assessments, so that all sites in the NL can use eSRA to assess their systems. Our vision is that all clinical research sites in the Netherlands will be assessed using eSRA and to facilitate eSRA recognition by all sponsors and regulators. We are very grateful to the eClinical Forum for providing this free tool.”
The EHR working group is planning further roll out to more clinical research sites in the NL and mutual acceptance by pharmaceutical companies such that eSRA can replace their own questionnaires. They believe this will avoid duplication of efforts by the completion of various forms and it will contribute to more efficient and reliable data collection in clinical trials.
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Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data
In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.
The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.