ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor
Manufacturer acting as sponsor

Regular Termination - Declaration timespan (max nr days)

Not specified

Early/premature Termination - Declaration timespan (max nr days)

Not specified

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form available

No

Standard Declaration form

Use of form B6 possible.

Guidance on End of trial declaration

Related information is provided on CCMO website in section Home>Investigators>During and after the research>End of study

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