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BCG Vaccine...
About the DAIDS Trial Master File Team
The DAIDS Trial Master File (TMF) Team is a team within the DAIDS Office for Policy in Clinical Research Operations (OPCRO) Office of the Director (OD) responsible for ensuring the overall health of DAIDS TMFs, establishing protocol specific TMF management…
Moxifloxacin (Avelox)...
Moxifloxacin (Lonxave)...
Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir...
ChAdOx1.HIVconsv62...
ChAdOx1.tHIVconsv1...
MVA.tHIVconsv3 Vaccine...
MVA.tHIVconsv4 Vaccine...
Vesatolimod (GS-9620)...
Rifampicin/Isoniazid...
Rifampicin...
Rifampicin/Isoniazid...
INO-6160 and INO-6172...
Veeva Vault is a secure, cloud-based, regulated content management system that is used to house sponsor TMF documents specified in the DAIDS TMF Index for DAIDS eTMFs managed by the RSC. It has been qualified and approved by DAIDS to maintain TMF documents from DAIDS and applicable vendors. …
The DAIDS Trial Master File (TMF) Team is a team within the DAIDS Office for Policy in Clinical Research Operations (OPCRO) Office of the Director (OD) responsible for ensuring the overall health of DAIDS TMFs, establishing protocol specific TMF management documents, and collaborating with…
General TMF Questions
TMF Access
Filing Questions
Regulatory Support Center Veeva Vault
Other Electronic Systems
DAIDS Oversight
Revised version of the FAQs coming soon
Revised version of the FAQs coming soon
GLA-SE...
MVA-CMDR...
p24CE1/2 multivalent pDNA Vaccine expressing HIV M Group p24 Gag and p55 gag pDNA with IL-12 pDNA...
RSV 276...
RSV D46/NS2/N/deltaM2-2-HindIII...
RSV DeltaNS2-Delta1313-I1314L...
IHV01...
VRC-HIVADV014-00-VP (Multiclade rAd5 HIV-1 Vaccine) and rAd5 component vaccines...
VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP Combination...
VRC-HIVMAB060-00-AB (VRC01)...
Lists of IND and non-IND protocols having case report forms (CRFs) and pharmacy records that will not be stored by DAIDS .
CRF master inventory list template.
List of IND protocols having CRF/Pharmacy records that will not be stored by DAIDS.
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.
Instructions for the transfer of case report forms, (CRF) and pharmacy records to the DAIDS regulatory support center, (DAIDS RSC).
Protocol Development Lifecycle flowchart
Division of AIDS review of imformed consent forms, impact of the HIPAA privacy rule.
DAIDS ClinicalTrials.gov Protocol Checklist, version Date: 20 Nov. 2015...
Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.
DAIDS protocol specific informed consent template—general use.
Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.
DAIDS sample Informed consent template, stored samples and associated health information for future research use.
Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.
Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.
DAIDS letter of Amendment template for a protocol.
DAIDS expedited adverse event (EAE) reporting template.
DAIDS final protocol template language for protocol registration (April 2010).
Guidance for implementing protocol clarifications or changes.
Worksheet designed to assign risk levels to protocols for prioritizing clinical site monitoring resources.
Letter of amendment flowchart for Protocol Teams.
DAIDS Protocol Risk Worksheet...
DAIDS protocol risk ranking data capture and distribution standard operating procedure, worksheet and flow chart.
Study statuses and milestones handout.
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.
Quick reference card for creating a new submission in the DPRS.
DAIDS investigator of record form (7/2020).
Quick reference card for protocol registration at a glance.
DAIDS protocol registration timelines.
DAIDS protocol registration basic training.
Process for collection of financial disclosure by clinical investigators conducting DAIDS-sponsored IND trials.
Clinical investigators disclosure of financial interests and arrangements.
MTN financial disclosure/certification form.
Non-network financial disclosure/certification form.
AIDS clinical trials group network IND study financial disclosure form.
.zip file includes
ACTG Network IND Study Financial Disclosure Form (PDF)
ACTG Network IND Study Financial Disclosure Form Template (PDF)
ACTG Network IND Study Financial Disclosure Form Fillable (PDF)
Clinical Research Sites...
BG505 SOSIP.664 gp140, Adjuvanted with 3M-052-AF + Alum, or CpG 1018 + Alum, or GLA-LSQ, or Alum...
Darunavir/Cobicistat (Prezcobix) Package Insert...
Abacavir/Lamivudine (Epzicom) Package Insert...
Financial Disclosure Form for HVTN...
The updated Financial Disclosure Form for HVTN is now available on the DAIDS Financial Disclosure Forms page.
PGT121.414.LS (VRC-HIVMAB0107-00-AB)...
The updated Financial Disclosure Form for HPTN is now available on the DAIDS Financial Disclosure Forms page.
Clofazimine (Lamprene) Package Insert...
Rifampicin Package Insert...
Ethambutol Hydrochloride Package Insert...
Pyrazinamide Package Insert...
N-803...
Azithromycin Package Insert...
Hydroxychloroquine Sulfate Package Insert...
CH505 M5 gp120...
DAIDS Protocol Registration Policy and Manual Training 2019 - PowerPoint...
ACTG IND study financial disclosure form template.
The updated Financial Disclosure Form for ACTG is now available on the DAIDS Financial Disclosure Forms page.
The following serious and life-threatening side effects have been associated with the use of rilpivirine:
Severe skin rash and allergic reactions. If you get a rash with any of the following symptoms, stop taking RPV and call the study doctor or your healthcare provider right away:
Fever…
CH505 TF chTrimer...
Remdesivir (Veklury)...
Memorandum— DAIDS ClinicalTrials.gov Protocol Checklist...
DAIDS Clinicaltrials.gov Protocol Checklist...
The updated DAIDS ClinicalTrials.gov Protocol Checklist has been posted and can be accessed on the DAIDS ClinicalTrials.gov Protocol Checklist page.
Clinical investigators disclosure of financial interests and arrangements.
Financial Disclosure Form for IMPAACT...
The updated Financial Disclosure Form for HPTN is now available on the DAIDS Financial Disclosure Forms page
DAIDS TMF Resources SharePoint
DAIDS TMF Resources SharePoint SiteNote access to the SharePoint site requires login.
TMF Fundamental Documents
TMF Fundamental Documents TrackerVersion 18.0 - June 2025
NIAID Policy Related Documents
DAIDS TMF Index Guiding PrinciplesVersion 1.0 - July 2022
Guidance…
Dasatinib...
Quercefit (Quercetin Phospholipid)...
VRC-HIVMAB075-00-AB (VRC07-523LS)...