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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
A new Trial Master File page is now available on the DAIDS RSC website at https://rsc.niaid.nih.gov/networks-protocol-teams/tmf.
Estradiol...
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…
Cabotegravir and Rilpivirine (Cabenuva)...
Tenofovir Enema Formulation...
CD4BS CH505M5 Pr-NP1, Adjuvanted...
Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) Package Insert...
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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...
mRNA-1645-eODGT8 and mRNA-1645-CoreG28v2...
HxB2.WT.Core-C4b, Adjuvanted...
VIR-1778...
Estradiol gel...
Progesterone...
UVAX-1197 / UVAX-1107, adjuvanted with 3M-052-AF + Alum...
CD40.HIVRI.Env (VRIPRO)...
Poly-ICLC (Hiltonol)...
Rifapentine...
DV700P-RNA and DV701B1.1-RNA...
Placeholder for DAIDS Regulatory Support Center (RSC)
Temporary importation of Bleomycin Sulfate Powder for Injection, 15,000 International Units (IU) to address drug shortage issue
COMBIVIR, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
INTELENCE® is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor(NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older with viral strains resistant to an NNRTI and other antiretroviral agents.
Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, lactose monohydrate, pregelatinized starch (corn), povidone and stearic acid.
The fixed-dose combination (Efavirenz 600 mg/ Emtricitabine 200 mg/Tenofovir disoproxil fumarate 300 mg) is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults.
NORVIR is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.
Vepesid is used in the treatment of certain types of cancer, in particular small cell lung cancer and testicular cancer.
Therapeutic Indications:
Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with (cisplatin or carboplatin)In…
ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated: * In combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older (1). The use of other active agents with ISENTRESS is associated with…
Ribasphere is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…
Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…
PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more anti-tuberculosis (anti-TB) drugs to which the isolate is susceptible. (1.1) *…
EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated - in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients with HIV-1 RNA less than or equal to 100,000 copies/…
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1) VIREAD is indicated…
SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product. Each SEPTRA Tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.4 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium…
Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin’s disease, non–Hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms’ tumor.
RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for:* Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1) * Prevention of maternal-fetal HIV-1 transmission. (1.2)
MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white…
Rifampin is indicated in the treatment of all forms of tuberculosis.
Presentation on expedited reporting to DAIDS plus a case study on expedited reporting via DAERS.
Guidance table for grading the severity of adult and pediatric adverse events with female genital involvement during microbicide studies.
Guidance table for grading the severity of adult and pediatric adverse events with male genital involvement during microbicide studies.
Line by line instructions for how to complete the Expedited Adverse Events reporting form.
Term definitions and access rights for Reporters and Submitters using DAERS.
Formatted specifically for printing. applicable, to special instructions to keep in mind while entering values.
Technical guide to the DAERS system for Site Enrollment users.
Detailed manual on the DAERS system for Site Reporters and Study Physicians.
Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. This version does not visually show changes with highlighting.
Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. Changes are highlighted visually within the document.
Expedited reporting form for Adverse Events fillable using Microsoft Word.
Presentation from webinar on using the Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0.
Use this to make sure you don't miss any required pieces of information when recording and reporting an adverse event.
One-sheet references for writing a narrative case summary of an adverse event and for evaluation and follow-up.
Zip file contains:
Presentation slides from ACTG June 2014 network meeting
Presentation to ACTG about expedited reporting on Adverse Events
Presentation to ACTG about reporting via DAERS
Case study on Adverse Events
Case Study on chest pain
.zip file contains:
Presentation slides from November 2014 webinar training on adverse events
Study handout accompanying training
Presentation about expedited reporting on Adverse Events
Presentation about reporting via DAERS
Case study on Adverse Events
Case Study on chest pain
Definitions of the types of safety information distributed by DAIDS and methods of distribution.
Training workshop in Durban, SA supporting documents:
Case Review: All About AEs - Safety Training
Expedited Reporting and Assessment - Safety Training
Expedited Reporting via DAERS - Safety Training
Expedited reporting via DAERS - Case Study
Training workshop in Johannesburg, SA supporting documents:
Case Review: All About AEs - Safety Training
Expedited Reporting and Assessment - Safety Training
Expedited Reporting via DAERS - Safety Training
Expedited reporting via DAERS - Case Study