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Cover Memo, January 18, 2017, RE: Lists of IND and non-IND protocols having Case Report Forms (CRFs) and Pharmacy Records that will not be stored by DAIDS

Lists of IND and non-IND protocols having case report forms (CRFs) and pharmacy records that will not be stored by DAIDS .

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DAIDS Deregistration

Guidance regarding the DAIDS deregistration process.

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DAIDS Financial Disclosure Guidance

Process for collection of financial disclosure by clinical investigators conducting DAIDS-sponsored IND trials.

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IND Protocol Lists

List of IND protocols having CRF/Pharmacy records that will not be stored by DAIDS.

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Instructions for Authorization and Transfer of CRFs and Pharmacy Records to the DAIDS RSC

Instructions for the transfer of case report forms, (CRF) and pharmacy records to the DAIDS regulatory support center, (DAIDS RSC).

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Non-IND Protocol Lists

Completed Non-IND studies that have met or exceeded the 3 year retention period (per 45 CFR 46.115); CRFs and pharmacy records will not be stored by DAIDS.

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Required Documentation Based on 45 CFR 46

Required documentation of risk/benefit category and approval of clinical studies for inclusion of children by institutional review boards/ethics committees based on 45 CFR 46, Subpart D.

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