As sponsor, NIAID DAIDS is required to monitor DAIDS sponsored and/or supported clinical trials to ensure protection of human subjects, accurate and complete reporting of trial data, and protocol compliance by Clinical Research Sites (CRSs), in accordance with 21 CFR §312.56 and ICH Good Clinical Practices (GCP) Section 5.18. The Monitoring Operations Branch (MOB) in the Office of Clinical Site Oversight (OCSO) directs the monitoring function for DAIDS-sponsored clinical trials to meet the rigor of all applicable regulations and guidelines.
DAIDS Network studies are being conducted in over 20 countries. The monitoring activities at these Clinical Research Site (CRS) locations are conducted by a Clinical Research Organization (CRO) with a regional presence through a contract mechanism. The current NIAID Clinical Site Monitoring (NCSM) Contractor is Pharmaceutical Product Development (PPD) LP. The MOB develops, executes and provides oversight of the NCSM monitoring contract.
To monitor the progress of the DAIDS clinical trials and adherence to all applicable regulations and DAIDS policies and procedures, PPD Clinical Research Associates (CRA)s in each region perform routine on-site and remote visits at each CRS. The MOB in conjunction with PPD ensures that the monitors are appropriately trained, as required by ICH/GCP.
To enhance human subject protection and the quality of clinical trial data, MOB monitoring oversight focuses on the most important aspects of study conduct and reporting. The MOB has developed and implemented tools to support risk-based monitoring. We continue to evaluate the efficiency and effectiveness of new monitoring strategies and will provide regulatory guidance including a Monitoring 101 training.
Related Training Courses on the DLP
|Name||Description and Audience|
|Monitoring 101||Overview of the DAIDS Monitoring process. Site staff members who will be involved with DAIDS monitoring visits or address monitoring issues should take this training.|
|Clinical Site Monitoring (CSM) System Training||Overview of the DAIDS Clinical Site Monitoring (CSM) System within the NIAID CRMS. Clinic and pharmacy staff members who will interact with clinical site monitors and address monitoring issues in the CSM system should take this training.|
|Clinical Quality Management Plan||
Four modules regarding site Clinical Quality Management Plan (CQMP) requirements, and associated tools. Site staff members who will be involved with Quality Management at the site should take this training.
|Corrective and Preventative Actions (CAPA)||Define what a CAPA is, how it is developed, and when it is used. All clinical and pharmacy staff members who will be addressing queries and CSM issues should take this training.|
|Inspection Awareness & Preparedness for CRS Inspections||Three modules giving an overview of what regulatory inspections at a CRS involve, what can be expected, and how to prepare. All personnel who would expect to be involved with a site inspection should take this training.|
|Inspection Awareness for Sponsor and CRO Inspections||Three modules giving an overview of what regulatory inspections at a Sponsor or CRO will involve, and what can be expected, both from the FDA and the EMA perspective. DAIDS and Network personnel are the audience for this training.|