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.

Clinical Research Site (CRS) Coordinator Onboarding Checklist

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. 

New CRS Coordinator Checklist


Clinical Research Coordinator Onboarding Resources

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


Electronic Informed Consent Resources

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. 

Financial Disclosure and Conflict of Interest Guidelines

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


Site SOP Templates

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

Age and Identity Verification
DAIDS Template

Verifying Age and Identity
HVTN Template

Co-enrollment Prevention
DAIDS Template

Example SOPs
The following examples were provided as a courtesy by each respective site. 
Milton Park CRS Age and Identity Verification SOP (including co-enrollment prevention procedures)
Setshaba Research Centre Biometric Co-enrolment Prevention System SOP

Electronic Systems
HVTN Template

Site Monitoring
HVTN 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