Lists of IND and non-IND protocols having case report forms (CRFs) and pharmacy records that will not be stored by DAIDS .
Guidance regarding the DAIDS deregistration process.
Process for collection of financial disclosure by clinical investigators conducting DAIDS-sponsored IND trials.
Guidance and requirements for daids-supported research involving recombinant DNA.
List of IND protocols having CRF/Pharmacy records that will not be stored by DAIDS.
Instructions for the transfer of case report forms, (CRF) and pharmacy records to the DAIDS regulatory support center, (DAIDS RSC).
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.
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.