EMA Expands Use of Remote Source Data Verification in Clinical Trials
The European Medicines Agency (EMA) will now permit remote source data verification (rSDV) in trials dealing with serious or life-threatening conditions as long as measures are in place to protect patients’ private data.
The remote option is allowed in cases in which critical data must be verified to avoid unacceptable risks to participants’ safety or the reliability or integrity of trial results, the guidance says. The EMA also expanded rSDV in cases “involving particularly vulnerable participants, such as children or those temporarily or permanently incapable of giving their informed consent.”
Before using rSDV, the EMA said, trials should have a plan for protecting patients’ privacy that could include such features as a policy on how a site can share deidentified participant documents with CRAs, security controls that limit remote access to patients’ electronic medical records or a system for video review of medical records that does not require sending data directly to CRAs and does not allow them to record images during the review.
Read the EMA’s guidance here: https://bit.ly/3q09sEp.