Our member companies have faced widespread clinical trial disruptions in the past few years – from the global pandemic to the war in Ukraine. A group of medical writing experts from ACRO, alongside their colleagues at TransCelerate came together and developed a proposal for how sponsors and CROs should report study disruptions in a Clinical Study Report (CSR).
ACRO and TransCelerate co-released the statement, which includes, “points to consider when developing a Clinical Study Report (CSR) for a clinical trial that has been disrupted due to unforeseen circumstances.” As clinical trials become increasingly global and complex, widespread disruptions will continue to occur. Our member companies remain committed to the continuity of trials and to patient safety amid any disruption.
Click Here for more CSR Resources from TransCelerate BioPharma
ACRO members are invited to download and share this statement and we encourage colleagues, customers, and other stakeholders to do the same.