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Annual Reports

Annual Progress Reports. Annual Safety Reports. Due anniversary of MHRA authorisation (or date of CTX/DDX letter) ____________ Reports sent to MHRA and Main REC must be identical. Due anniversary of Main REC favourable opinion _____________ REC will send reminder if overdue _____________

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Annual Reports

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  1. Annual Progress Reports Annual Safety Reports Due anniversary of MHRA authorisation (or date of CTX/DDX letter) ____________ Reports sent to MHRA and Main REC must be identical Due anniversary of Main REC favourable opinion _____________ REC will send reminder if overdue _____________ Can be submitted by sponsor, sponsor’s legal representative or CI Annual Reports See guidelines for content of report: Annual Safety Report Composition Guidelines Version 1.0 (11Jun08).doc Compose Safety Report. Suggested template letter: MHRA Annual Safety Report Letter (CTA).doc Complete Annual Progress Report Form (typed): REC Annual Progress Report Form (CTIMPS).doc Complete standard covering form: REC Safety Report Cover Form.doc Submit Safety Report as electronic document on disc to MHRA Information Processing Unit within 60 days of end of the reporting period CI must sign form Submit Safety Report & Cover Form to Main REC within 60 days of end of the reporting period Submit paper copy to Main REC within 30 days of end of the reporting period MHRA will acknowledge receipt Main REC will acknowledge receipt Main REC will acknowledge receipt by signing and returning a copy of the Covering Form Annual Reports Flow Chart – Final v1.0 10-06-2010

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