Topic: ? Archival period for Canadian Submission Studies (Read 106 times)

J Arul Jothi · « **on:** March 15, 2010, 05:29 PM »

Dear all,

Please let me know the archival period of study related documents (Trail Master File) for Canadian submission studies.

Thanks in advance.

Devoirs
Arul Jothi J

Clin_DM · « **Reply #1 on:** March 16, 2010, 06:36 AM »

Quote from: J Arul Jothi on March 15, 2010, 05:29 PM

Dear all,

Please let me know the archival period of study related documents (Trail Master File) for Canadian submission studies.

Thanks in advance.

Devoirs
Arul Jothi J

I think it is 25 years. Please find the attached document - GUIDANCE FOR RECORDS RELATED TO
CLINICAL TRIALS FOR CANADA

Section 5.2.4 of this document says - The sponsor shall maintain all records referred to in this Division for a period of 25 years.

Regards,
Clin_DM

Author Topic: ? Archival period for Canadian Submission Studies (Read 106 times)

J Arul Jothi

? Archival period for Canadian Submission Studies

Clin_DM

Re: ? Archival period for Canadian Submission Studies

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