That is a great question and I believe it is absolutely important to align protocol templates to reduce the amount of work towards the end when it is time to comply with these transparency regulations. It also helps in streamlining efforts on various regulations and minimize duplication of efforts as output could be bundled together to achieve maximum transparency and consistency across various public portals.
Dear all,This topic has been and continues to be incorporated into TransCelerate's Common Protocol Template.http://www.transceleratebiopharmainc.com/videos/transcelerate-common-protocol-template//http://www.transceleratebiopharmainc.com/assets/common-protocol-template/Jean Sposaro
Director Program ManagementRegulatory Council AdvisorSponsors SubcommitteeTransCelerate BioPharma Inc.
And also the core-reference has inputs on disclosure-readiness in the CSR template.