Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials
Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation… Expand article to read more...
Agenda Available … eClinical Forum 2017 Global Meeting, Reykjavik, Iceland, May 7-10 2017.
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We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.
Re-Posted from eCF LinkedIn Group
The FDA and OHRP published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent. Expand the article to read more
The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers. Expand the article to read more and to access the documents.