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The DAIDS Regulatory Support Center (RSC) is making every effort to ensure that the information available on our website is accessible to all. If you use special adaptive equipment to access the web and encounter problems when using our site, please e-mail us and we will provide the information to…
You have questions, DAIDS RSC has the answers
Choose a topic from the menu to view lists of questions and answers.
Search the FAQs using the search box at the top right of the page.
Have a question that you cannot find an answer to? Contact DAIDS and the DAIDS RSC.
About Personnel Information and the DAIDS RSC Clinical Study Information Office (CSIO)
The DAIDS RSC Clinical Study Information Office (CSIO) receives and abstracts staff contact information into the DAIDS-ES Master Contact module within NCRMS for use by the NIAID/DAIDS and their collaborators in…
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The DAIDS Protocol Registration System (DPRS) does not allow me to select my site number; thus registration materials cannot be submitted at this time. What do I do next?
You must contact your DAIDS Program Officer or OCSO representative so that your status can be updated.
The DPRS…
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Is it acceptable to include only a concise sample informed consent in the protocol rather than both a standard and a concise one?
It is acceptable to use a concise consent form that meets all of the regulatory requirements found in 45 CFR 46.116 (i.e. all the required elements of…
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Does my protocol/amendment have to be submitted for P/CSRC Review?
Your Medical Officer or Program Officer can advise you on the requirements for C/PSRC Review.
I know that my protocol/amendment has to be submitted for P/CSRC Review. To whom do I submit the documents?
These documents…
ABT-267, ABT 333, ABT-450 and Ritonavir...
Dapivirine (Microbicide Gel)...
Dapivirine (Vaginal Ring)...
Dapivirine-Levonorgestrel (Vaginal Ring)...
Delamanid (OPC-67683)...
Dolutegravir (GSK1349572)...
Doravirine (MK-1439)...
Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A)...
Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) - Investigator's Brochure...
Etravirine (TMC125, Intelence) Investigator Brochure...
GSK1265744 (Cabotegravir)...
HEC Placebo Gel...
Rifapentine...
Rilpivirine (TMC278, Edurant) Investigator Brochure...
DNA Mosaic-Tre env DNA Vaccine...
DNA-HIV-PT123...
DNA-HIV-PT123/NYVAC-HIV-PT1/NYVAC-HIV-PT4 vaccine...
EnvSeq-1 Vaccine (CH505TF gp120)...
A new Trial Master File page is now available on the DAIDS RSC website at https://rsc.niaid.nih.gov/networks-protocol-teams/tmf.
16055 NFL Delta Gly4 Env Protein Trimer, Adjuvanted with 3M-052 AF + Alum...
HIV-1 Adenovirus Type 4-Vectored (A549 cells) Vaccines (Ad4-Env150KN and Ad4-Env145NFL)...
Relevant Communications and Vendor Oversight Communication...
RSC Veeva Vault eTMF Submission Form...
DAIDS TMF Index Guiding Principles...
Guidance for DAIDS Electronic Trial Master Files...
DAIDS Protocol Change Process Policy...
DAIDS Protocol Change Process Job Aid...
V3G CH848 Pr-NP1, Adjuvanted and V3G CH848 mRNA-Tr2...
MTBVAC (New Generation Live-Attenuated Tuberculosis Vaccine)...
N332-GT5 gp140, Adjuvanted with SMNP...
DAIDS CRSS ClinicalTrials.gov Initial Registration Process...
How to Initiate the ClinicalTrials.gov Initial Registration Process Memorandum...
DAIDS TMF Index Recording...
New ClinicalTrials.gov initial registration training documents are now available on the DAIDS RSC website at https://rsc.niaid.nih.gov/networks-protocol-teams/clinicaltrialsgov.
ClinicalTrials.gov Flowcharts...
The updated DAIDS ClinicalTrials.gov Protocol Checklist has been posted and can be accessed on the DAIDS ClinicalTrials.gov page.
TMC207 (Bedaquiline)...
TBI-223...
Sutezolid (PNU-100480)...
Ethambutol...
ID93 + GLA Adjuvant Formulation Vaccine...
3BNC117-LS (-J)...
10-1074-LS(-J)...
A new SharePoint site has been created for DAIDS TMF Resources with the following link on the DAIDS electronic Trial Master File (eTMF) Resources page: DAIDS TMF Resources SharePoint Site.
BG505 SOSIP.GT1.1 gp140 Vaccine...
Cabotegravir (Vocabria)...
Effective April 1, 2024, per DAIDS’ decision, a TMF Submission Form will not be required for TMF documents uploaded to the DAIDS RSC Veeva Vault (VV) eTMF system for any study.
Please note that a TMF Submission Form will be required for TMF documents uploaded to the DAIDS RSC VV eTMF system through…
Language concerning Case Report Form and pharmacy record retention have been updated on the CRF and Pharmacy Record Management page as well as the Records and Case Report Forms FAQs.
Additionally, updated lists of protocols having CRF/pharmacy records that will NOT be stored by DAIDS have been…
Tenofovir Enema Formulation...
CD4BS CH505M5 Pr-NP1, Adjuvanted...
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Who should I contact if I have any TMF related questions?
Please contact DAIDS TMF Team at NIAIDDAIDSTMF@mail.nih.gov.
Where can I find the fundamental documents for established eTMFs (i.e., TMF Plan, Electronic Systems Mapping Document, TMF Index, etc.)?
You can download a copy of…
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There is a new team member who needs access to the DAIDS TMF. Who should I contact?
Send an email request to the DAIDS TMF Team NIAIDDAIDSTMF@mail.nih.gov. Your request should include your new team member's:
Name
Email address
Study role (e.g., DAIDS TRP/PSP MO…
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How do I know under which zone, artifact, and sub artifact I should upload a specific document in the TMF?
The DAIDS TMF Index has information on the DAIDS-specific sub-artifacts/document location as well as the definition/purpose for each artifact. If there is a specific document…
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I do not have access to the RSC Veeva Vault for a specific study. Who should I contact?
Requests for access to a specific study in the RSC Veeva Vault system must be sent to the DAIDS TMF Team (NIAIDDAIDSTMF@mail.nih.gov) for approval. At minimum, your request must include your:
Name…
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Are ESOs required to deliver quarterly eTMF Reports to the DAIDS TMF Team under the updated DAIDS TMF processes?
Effective February 1, 2024, ESOs do not need to send quarterly reports. The DAIDS TMF Team will meet with system owners to discuss and review reports generated by system…
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How do I perform TMF oversight of the RSC Veeva Vault?
Details on how to perform oversight activity can be found in the DAIDS QMS Work Instruction DAIDS-OPC-A15-WI-00002 DAIDS Primary Contact (PC) Oversight of TMF Documents. Additional training related to this topic is covered in the…
CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160...
3M-052-AF...
Escitalopram Oxalate...
Pramipexole Dihydrochloride...
mRNA-1645-N332GT5...
For help with the DAIDS RSC website please contact:
Jessica Holden, Ph.D., RACEmail: DAIDSRSCwebsitesupport@tech-res.comPhone: 1 (301) 897-1783
For assistance from the DAIDS Office for Policy in Clinical Research Operations or from other areas of the DAIDS Regulatory Support Center (RSC) please…
Vorinostat (Zolinza)...
The “DAIDS Therapeutic Research Program Guidance for the Development of Protocol Procedures to Address Reproductive Risk” is now available on the Protocol Templates page.
DAIDS RAB is a branch of DAIDS within the Office of Policy in Clinical Research Operations (OPCRO). RAB is responsible for regulatory strategy across the DAIDS programs. RAB performs regulatory management and surveillance and is the official DAIDS liaison to the U.S. FDA for clinical trials…
The DAIDS RSC Regulatory Support Center (RSC) Website has been your go-to place for information on regulatory aspects of DAIDS clinical trial operations for over 10 years. With a fresh look, the new DAIDS RSC Website continues to provide current information to facilitate Adverse Event Reporting,…
Tamoxifen Citrate Tablets USP, a nonsteroidal antiestrogen, are for oral administration.
ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies
Sofosbuvir/Velapatasvir (Epclusa)...
Purpose: To define general informed consent procedures. Scope: This procedure applies to all staff involved in obtaining informed consent. (Adapted from the Microbicide Trials Network)
Purpose: To define informed assent/permission/consent procedures for potential participants who are children. Scope: This procedure applies to all staff involved in obtaining informed assent, parental permission, and consent when children are research participants. (Adapted from the…
The updated Financial Disclosure Form for HPTN is now available on the DAIDS Financial Disclosure Forms page.
Glossary of Protocol Development Terms
Term
Definition
Consensus Review
A Consensus Review is a summary of the C/PSRC meeting that communicates the C/PSRC comments and decision to the Protocol Team.
CSRC
The Clinical Scientific Review Committee (CSRC) is the Division of AIDS internal…
Download a PDF version of the Protocol Development Lifecycle
Status Milestones
Study Status
Milestone
Entity and Key Points
Proposed
The network leadership has decided to commit resources on the proposal. For non-network initiatives, DAIDS has decided to commit resources on the…
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...
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...
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)...