Prospective planning · medium severity
Every protocol and SAP version is retained and handed over
The reviewer has to be able to see what the plan said at each point. A single final file, with earlier versions discarded, cannot show whether a choice changed after the data arrived.
The check
Does the outline say the protocol and SAP versions are kept and available to the reviewer?
What the outline has to carry
- version control
- retention and handover
A check is met only when every element above is present. One element on its own is a partly evidenced check, not a pass.
What resolves it
List the protocol and SAP versions with dates, say where they are held, and state that every version goes into the trial master file and the submission, not only the latest.
The source sentence
Those conditions can be specifically about the protocol, enrollment targets, milestones, and a target completion date.FDA Watch, 20:55 to 21:53
The quotation is short and is used to show the sentence the rule is read from. The rule itself is our statement, not the speaker's words.
The legal basis
The held frameworks that bear on this check, with the control each one contributes. The link opens the framework page so the reader can check the source.
Essential documents, trial master file and retention
The essential documents are held in a trial master file and retained for the period the applicable law requires.
International · Read the framework
Record protection, retention and inspection readiness
Records can be produced in a readable form for the whole retention period, and are available for inspection when asked for.
United States · Read the framework
Try it on your outline. The free check applies this rule and quotes the line it read.