Supporting the Success of Network Clinical Trial Sites
The resources below are intended to harmonize site-level procedures and address issues of common concern among clinical research sites.
The HANC Cross-Network Site Coordinators Working Group (SCWG) developed an onboarding/training checklist to be used as a guide for new Clinical Research Site (CRS) Coordinators.
The Association of Clinical Research Professionals (ACRP) developed the ACRP Entry-Level Clinical Research Coordinator (CRC) Competency Development and Assessment Roadmap to standardize and facilitate the onboarding, training, and development of new CRCs. This roadmap enables greater consistency in expectations, career guidance, and performance quality of CRCs. Download the document on the ACRP website.
In March 2022, HANC hosted a two-part webinar series exploring the regulatory foundations and implementation of electronic informed consent in clinical trials. Webinar recordings and slides from the sessions can be found below and on the HANC Webinars & Presentations page:
- eConsent 101: Regulatory Foundations Recording / Slides. Presenters: Linda Ehler, DAIDS OPCRO ProPEP; Jui Shah, DAIDS OPCRO ProPEP; and Jose Pablo Morales, US Food and Drug Administration.
- eConsent in Practice: Perspectives from Sites Recording / Slides / Extended Q&A. Presenters: Chris Jonsson, University of Washington AIDS Clinical Trials Unit; Fatima Mayat, Perinatal HIV Research Unit; Rita Sondengam, Bronx Prevention Center CRS.
The guidelines are intended to identify significant financial interests of network-affiliated researchers and avoid conflicts of interest, or the appearance of such conflicts, in activities of the networks. Network Leaders approved the guidelines on the April 2010 Network Leaders call and the document has been adopted as standard operating procedure for all networks effective April 15, 2010.
NIAID HIV/AIDS Clinical Trials Networks Financial Disclosure and COI Guidelines SOP
Version 13.0 of the “NIAID (DAIDS)-supported and/or Sponsored HIV/AIDS Clinical Trials Networks Financial Disclosure and Conflict of Interest Guidelines”.
Last updated June 17, 2024
Additional financial disclosure guidance for investigators can be found at the following sources:
National Institutes of Health (NIH) FDCOI Guidance
Food and Drug Administration (FDA) FDCOI Guidance
The following templates are provided to assist sites in developing CRS SOPs and meet the List of Required SOPs at DAIDS CRS.
Additional templates will be added as they become available.
Last updated May 23, 2022
Data Systems and Management
HVTN Template
Handling Confidential Participant Information/Sensitive Data Storage
HVTN Template
Power Failure and Natural Disasters
HVTN Template
Randomization
HVTN Template
Electronic Systems
HVTN Template
Handling Laboratory Results
HVTN Template
Coordination with the Pharmacy
HVTN Template
Accrual
MTN Template
Basic Infection Control Practices
HVTN Template
HIV Counseling and Testing
HVTN Template
Intimate Partner Violence and Sexual Assault Support and Follow-up
MTN Template
Medical Emergencies
HVTN Template
Medical Emergencies for South African CRSs
HVTN Template
Verifying Eligibility
HVTN Template
Eligibility Determination
MTN Template
DAIDS Protocol/Sample Informed Consent Template - General Use
DAIDS Template
Obtaining Informed Consent
MTN Template
Obtaining Informed Consent
HVTN Template
Unblinding
HVTN Template
Audits/Inspections of CRSs by Other Agencies/Regulatory Authorities
HVTN Template
Inspection Preparedness
DAIDS Template
Communications with Sub-Units and Sub-Contractors
HVTN Template
Creation of Standard Operating Procedures
HVTN Template
Clinical Quality Management Plan
DAIDS Template
Translations
MTN Template
Equipment Maintenance and Calibration
HVTN Template
General Operations
HVTN Template
Informed Consent Development
HVTN Template
Management of Essential Documents and Source Documentation
HVTN Template
Retention of Clinical Research Records
HVTN Template
Management and Reporting of AEs/SAEs/EAEs
HVTN Template
Safety Monitoring
MTN Template
Site Monitoring
HVTN Template
Delegation of Duties Log
DAIDS Template
SOP Training Log
HVTN Template
Training log (Trainee specific)
DAIDS Template
Training Log (Training Topic specific)
DAIDS Template
Blank SOP Template
DAIDS Template
Blank SOP Template
HVTN Template
Blank WPG Template
HVTN Template
Calibration Log
HVTN Template
Clinical Research Site Visit Log Template
DAIDS template
Essential Documents Table
HVTN Template
Log of Copied Documents
DAIDS Template
Maintenance Log
HVTN Template
Note to File
DAIDS Template
Power Failure Log
HVTN Template
SOP Deviation Report
HVTN Template