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Guidelines for Electronic Submissions Via Email-EPR Guidelines
Monthly Comprehensive Safety Distribution Report (CSDR) FAQ...
Isoniazid Package Insert...
DAIDS Memo Regarding Timing of Consent and Re-Consent with Updated IRB/EC/RE-Approved Informed Consent Forms.
A DAIDS Memo regarding timing of consent and re-consent with updated IRB/EC/RE-approved informed consent forms has been posted to the Informed Consent Process Page on the Clinical Research Sites tab.
Instructions for Authorization and Transfer of CRFs and Pharmacy Records to the DAIDS RSC...
The process of electronically distributing Investigator’s Brochures (IBs) has now been initiated for DAIDS Clinical Research Sites (CRSs). For more information on this process, view the Safety Information Distribution Page and the RIC FAQs.
All Clinical Research Sites (CRSs), where required by country regulation or law, must have secured clinical trials insurance for every new and ongoing clinical trial sponsored by DAIDS to ensure compliance with the European Medicines Agency Committee for Proprietary Medicinal Products, Art 5.8 CPMP…
The list of countries requiring clinical trials insurance has been posted to the Clinical Trial Insurance page.
Abacavir Sulfate/Dolutegravir/Lamivudine (Triumeq) Package Insert...
Intralipid...
Clinical Trial Application Submission Guidance...
DAIDS Clinical Trial Application Submission Checklist...
Signature Requirement Guidance...
The updated DAIDS Protocol Registration Manual and Policy have been released and can be accessed on the Policy and Procedures Manual page. Supporting documents have also been posted on the Training and Resources page.
Levonorgestrel...
Updated versions of the “Lists of protocols having CRF/pharmacy records that will NOT be stored by DAIDS” are now available on the CRF Management page.
Got Questions? The DAIDS RSC has the answers.
The DAIDS Regulatory Support Center Team will be answering your questions at the MTN 2019 Annual Meeting.
Don’t miss this great opportunity to get guidance from the DAIDS RSC Team at our Information Booth. You can submit questions ahead of…
DAIDS Memo Regarding New DAIDS Requirements: Informed Consent Process...
Rifafour e-276 (Rifampin/Isoniazid/Pyrazinamide/Ethambutol)...
Rifabutin Package Insert...
RSV 6120/DeltaNS2/1030s...
PGT121...
PGDM1400...
Got Questions? The DAIDS RSC has the answers.
The DAIDS Regulatory Support Center Team will be answering your questions at the 2019 HVTN Full Group Meeting.
Don’t miss this great opportunity to get guidance from the DAIDS RSC Team at our Information Booth. You can submit questions ahead…
Got Questions? The DAIDS RSC has the answers.
The DAIDS Regulatory Support Center Team will be answering your questions at the 2019 HPTN Annual Meeting.
Don’t miss this great opportunity to get guidance from the DAIDS RSC Team at our Information Booth. You can submit questions…
Got Questions? The DAIDS RSC has the answers.
The DAIDS Regulatory Support Center Team will be answering your questions at the 2019 IMPAACT Annual Meeting.
Don’t miss this great opportunity to get guidance from the DAIDS RSC Team at our Information Booth. You can submit questions…
Got Questions? The DAIDS RSC has the answers.
The DAIDS Regulatory Support Center Team will be answering your questions at the 2019 ACTG Annual Meeting.
Don’t miss this great opportunity to get guidance from the DAIDS RSC Team at our Information Booth. You can submit questions…
CRS Leader and CRS Coordinator User Guides...
As of July 1, 2019, DAIDS started electronically distributing IBs to the CRS Leaders and CRS Coordinators through the NIAID CRMS EAE Reporting Module (DAERS). Information regarding this process has been posted to the Safety Information Distribution Page, including an updated Safety…
B63521^11 gp120...
Algorithm for Determining Whether Site Specific Informed Consent Forms will be Reviewed at the Time of Initial Protocol Registration...
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Genvoya) Risk List...
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.
Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) Package Insert...
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
The updated Financial Disclosure Form for IMPAACT is now available on the DAIDS Financial Disclosure Forms page.
2020 IND Lists of Studies having CRF/Pharmacy Records That Will Not be Stored by DAIDS...
2020 non-IND Lists of Studies having CRF/Pharmacy Records That Will Not be Stored by DAIDS...
Linezolid (Zyvox)...
CMV-MVA Triplex...
DAERS Access User Guide for EAE Reporter and Submitter Rights...
EnvSeq-1 and EnvSeq-2...
PGDM1400LS (VRC-HIVMAB0112-00-AB)...
mRNA-1574 Trimer Vaccines...
HIV-1 Vaccines AdC6-HIVgp140, AdC7-HIVgp140, CH505TF/GLA-SE...
GS-2872 (10-1074 LS)...
Rifampicin/Isoniazid...
Rifampicin/Isoniazid (Isonarif)...
Rifampicin/Isoniazid/Pyrazinamide/Ethambutol Hydrochloride...
Linezolid...
Doravirine (Pifeltro)...
426c.Mod.Core-C4b, Adjuvanted...
GS-5423 (3BNC117-LS)...
VRC-HIVRGP096-00-VP (HIV-1 Trimer 4571 Vaccine)...
Selgantolimod (GS-9688)...
Pretomanid (PA-824)...
Tecovirimat (TPOXX)...
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. …
DAIDS TMF Resources SharePoint
DAIDS TMF Resources SharePoint SiteNote access to the SharePoint site requires login.
TMF Fundamental Documents
TMF Fundamental Documents TrackerVersion 16.0 - April 2025
NIAID Policy Related Documents
DAIDS TMF Index Guiding PrinciplesVersion 1.0 - July 2022
Guidance…