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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)
Guidance regarding the DAIDS deregistration process.
HVTN IND study financial disclosure form.
Guidance and requirements for daids-supported research involving recombinant DNA.
Disclosure of financial Interests and arrangements form for IMPAACT Clinical Investigators.
Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).
Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).
DAIDS protocol registration translation confirmation document.
The DAIDS RSC is a contract-based organization that provides comprehensive clinical regulatory support to DAIDS for all NIAID/DAIDS-supported and/or sponsored network and non-network clinical trials, both domestic and international. These pages are designed to facilitate the most common…
The DAIDS Storage and Retention of Clinical Research Records Policy states:
For those clinical research records that are the property of the awardee institution, the institution is responsible for maintaining and retaining clinical research records in accordance with all applicable regulations,…
Effective July 1, 2014, any investigator (including sub-investigators) listed on the Form FDA 1572 must complete a financial disclosure form/statement for all DAIDS -sponsored and/or -supported studies where DAIDS holds the IND.
DAIDS Policy: Process for Collection of Financial Disclosure
November…
DAIDS Memo Regarding Timing of Consent and Re-Consent with Updated IRB/EC/RE-Approved Informed Consent Forms.
August 2018
DAIDS Memo Regarding New DAIDS Requirements: Informed Consent Process
August 2017
Please see the example Standard Operating Procedures below illustrating requisite…
About the DAIDS RSC Protocol Registration Office
The DAIDS RSC Protocol Registration Office (PRO) receives and processes all protocol registration materials submitted by Clinical Research Sites (CRSs) participating in DAIDS-supported and/or -sponsored clinical trials.…
Any CRS that has completed the DAIDS protocol registration process for a protocol (main or sub-study), must complete the DAIDS deregistration process for each protocol to which it is registered.
Note: Deregistration is NOT performed automatically when a study is completed.
Deregistration can…
The DAIDS Protocol Registration System (DPRS) is an internet based system that allows DAIDS Clinical Research Sites (CRSs) to submit and track all documents submitted to the DAIDS RSC Protocol Registration Office (PRO). The DPRS is part of the NIAID Clinical Research Management System (NCRMS…
Form FDA 1572: Statement of Investigator
FDA required document in which clinical investigators agree to conduct the clinical trials according to U.S. Federal regulations. The Form FDA 1572 is signed by the investigator and a copy is submitted to the IND Sponsor.
DAIDS Investigator of…
Registration Policy and Procedures Manual
Protocol Registration PolicyVersion POL-A15-OPC-003.00 - March 2019
Protocol Registration Procedures ManualVersion MAN-A15-OPC-001.00 -March 2019
Training on the DAIDS Protocol Registration Policy and Procedures Manual
The Protocol Registration…
Each CRS will complete the protocol registration process for all clinical research supported and/or sponsored by DAIDS that is reviewed by DAIDS Scientific Review Committees, namely the Prevention Sciences Review Committee (PSRC) and the Clinical Sciences Review Committee (CSRC), if it is…
Trainings
DAIDS Protocol Registration System (DPRS) Training (required)
The DPRS eLearning module is a self-paced training which can be accessed via the DAIDS Learning Portal. First, log in to the DAIDS Learning Portal (DLP) with your user name and password. Then enter DPRS into the search…
The below documents describe the processes and parties involved in the lifecycle of a protocol, the DAIDS-defined study statuses and milestones, and processes for implementing protocol changes and Letters of Amendment (LOAs).
Protocol Development Lifecycle
January 2017
DAIDS Study Statuses…
The below DAIDS templates should be consulted and used as appropriate when drafting protocol documents.
Protocol Registration Template
DAIDS Protocol Template Language for Protocol RegistrationApril 2010
Algorithm for Determining Whether Site Specific Informed Consent Forms will be Reviewed at the…
Submit a protocol for CSRC Review
Submit a protocol for PSRC Review
Submit a protocol for Regulatory Review
Submit a protocol for Medical Officer Review
Submit a protocol for RAB Review
DAIDS ClinicalTrials.gov Protocol Checklist
For DAIDS-held IND studies, the responsibility to meet the ClinicalTrials.gov reporting requirements falls within DAIDS. For other studies (e.g., network non-IND, non-DAIDS held IND, non-network non-IND, etc.), the responsibility generally lies with…
The DAIDS Protocol Risk Worksheet is designed to assign risk levels to protocols for prioritizing clinical site monitoring resources. To ensure consistency of responses, the guidelines should be referenced while completing the worksheet.
DAIDS Protocol Risk Worksheet Guidelines
Version 2.1 - …
The Division of AIDS Enterprise System (DAIDS-ES) Protocol Management module within NCRMS is a repository of key protocol information for Network and non-Network protocols supported by DAIDS. The Protocol Management module has approximately 250 fields available for the abstraction of…
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How long must the clinical research site maintain clinical research records?
Clinical research record retention requirements are to be determined on a trial-by-trial basis, taking into consideration: local, national regulations; NIH, NIAID, and DAIDS policies; and all applicable…
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How do I update contact information for site personnel in the DAIDS-ES?
Contact information for site personnel, such as office/mailing/shipping address, e-mail, phone and fax number, can be reviewed and updated by the site coordinator using the DAIDS-ES. Information regarding staff can…
Training & Access
Entering EAEs
Updating EAEs
Submitting EAEs
System Problems
Emergency Information
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How do I sign up for DAERS training? How will DAERS training be facilitated?
Training is provided in a web-based format that is designed to be self-paced to offer flexibility and accessibility. The training is a required part of the overall process of obtaining access to DAERS, and the…
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Why is it necessary to fill out additional EAEs when participants are on multiple studies? Is there a way that these can be completed once?
If the participant is co-enrolled on another DAIDS study:
Check the co-enrolled protocol(s) for EAE reporting requirements.
Submit a separate EAE…
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I need to update an EAE with a corrected death date in DAERS that occurred in Jan 2007. Upon updating the EAE with the corrected information, and doing a completion check, there were numerous incomplete fields. The EAE was in DAERS, but had no other information. Do we have to enter the…
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I submitted an EAE with the wrong PID #. How do I correct the PID #?
Once you have submitted the EAE, you cannot change the PID that was selected. However, if you have not yet submitted the Initial EAE (i.e., the status of the EAE report is either “Pending” or “Ready for Final Review…
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Sometimes there is quite a bit of lag time to reach the successfully saved on screen confirmation for each section. What should I do if the screen takes an unusually long to time to save the information for a section?
Internet connection speeds vary depending on circumstances at each…
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My physician/DAERS submitter is not available to submit the report in the DAERS system, but it is due now.
The reporter should enter the EAE report into the system, perform the Completion Check to put the EAE in the Ready for Final Review status, and then:
Send an e-mail to the…
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What does supported by NIAID/DAIDS mean? Does it mean financially supported?
In addition to financial support, “supported” also means direct and indirect funding, other types of tangible support, such as providing lab or data management services, regulatory support, study drug supply…
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When does this requirement take effect?
DAIDS requires collection of FD statements effective July 1, 2014. For ongoing studies it is advisable to collect them for all investigators listed on the most current Form FDA 1572.
When must FD forms/Statements be completed?
At the time a…
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How should names be listed on the Form FDA 1572/DAIDS IoR Form?
Sites should use the complete legal name (full first and last name) on all documents. It is recommended that sites use the name that appears on legal documents (e.g., medical license, passport, etc.) on all documents.…
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Since CVs are not protocol specific, do sites have to upload it for each protocol or can it be stored in a cross-protocol manner on the DPRS?
Sites do not have to submit a new CV for each submission to the DAIDS PRO as long as the CV on file has a signature and date that is less than 2…
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The Manual states that once a CRS has received approval from their IRB/EC and other applicable REs/Approving Entities, the amended protocol or LoA and revised site informed consent(s) must be implemented immediately. Can you clarify what is meant by immediately? Is there a window/grace…
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Is there a specific format or template for the written documentation sites must provide when a site deletes or makes any substantive change to basic and/or additional elements as presented in the DAIDS-approved sample informed consent (SIC)?
There is no specific format or template.…
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What does the term “REs/Approving Entity” include?
Any group other than the local IRB/EC who is responsible for reviewing and/or approving a clinical research protocol and site-specific ICFs prior to implementation at a site. Refer to the Definition section of the Protocol Registration…
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Will time requirements for documentation submitted to the Institutional Review Board (IRB)/ Ethics Committee (EC) also apply for consents that must be translated into other languages as well?
Sites should submit the amended protocol and all the amended site-specific ICF(s) to their…
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When is the latest point at which a site should complete deregistration?
Although deregistration can take place earlier, the latest that a site should deregister is after the primary analysis of the study is complete.
How do we know when the primary analysis is done?
Sites may…
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What are the steps required for DPRS access?
To gain DPRS access, DPRS training is required. Once the training is completed, a DPRS User name and password will be provided to access the system.
How do I sign up for DPRS training? How will DPRS training be facilitated?
The DPRS…
General
Financial Disclosure
Form FDA 1572/DAIDS IOR Form
Curriculum Vitae (CV)
Protocol Registration Submissions
Site Specific Informed Consent Form (ICF)
Entity Approvals
Translation Requirements
Deregistration
DPRS Access
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How do I know who the responsible party is for submitting information to ClincialTrials.gov?
If the applicable clinical trial involves an IND/IDE, the IND holder would generally be considered the sponsor and the responsible party under FDAAA. i.e. If DAIDS is the IND holder for a study…
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How can I obtain information on the National Clinical Trial (NCT) #?
Please check the ClinicalTrials.gov website first. If the NCT # is not available, contact the DAIDS RSC at regulatory@tech-res.com. The DAIDS RSC will forward your request to the DAIDS ClinicalTrials.gov Point of…
General Regulatory Questions
ClinicalTrials.gov and FDAAA Questions
Who are DAIDS collaborators? How are they involved in the protocol development lifecycle? And other information about collaborators.
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…