Sending a protocol amendment is easy. Proving who received the released version, and what happened to the superseded copy, is harder.
A distribution register gives the study team one place to check the handoff. It should identify the study, amendment number, protocol version, version date, release authority, approved distribution list, send time, receipt status, and any related training assignment.
Start from the released source
Administrative staff should take the file from the controlled repository or the location named by the document owner. They should not distribute a draft found in email. If the filename, version date, or approval state conflicts, stop and escalate.
Use the approved secure channel. Record the recipient and timestamp, but avoid placing participant information in the register.
Track receipt without overclaiming
Receipt, acknowledgment, training completion, and implementation are different events. Keep separate fields for each when the study process requires them. An email delivery notice does not prove that a recipient understood the amendment or changed study conduct.
Follow up on missing acknowledgments using the study's schedule. Route inactive contacts, bounced messages, and site roster changes to the study owner before adding a replacement recipient.
Retire superseded copies
Follow document-control instructions for marking, archiving, or removing prior versions. Do not delete records that the retention plan requires. Record the action and its owner.
A weekly exception view should show missing recipients, version conflicts, and overdue acknowledgments. The sponsor, investigator, institutional review board where applicable, and qualified study personnel remain responsible for approval, training sufficiency, and the effective date of implementation.
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