DAIDS requires CRSs conducting clinical research that meets the National Institute of Health (NIH) definition of a clinical trial to follow all applicable NIH, National Institute of Allergy and Infectious Diseases (NIAID), DAIDS policies and procedures, as well as DAIDS Clinical Trials Networks processes and procedures.
The Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual was developed to describe the operational requirements for Clinical Research Sites (CRSs) implementing DAIDS-sponsored studies within the DAIDS Clinical Trials Networks. However, many sections of the manual are broadly applicable to all clinical research and must be followed by CRSs conducting these studies. Access the DAIDS SCORE Manual here.
For the most frequently asked questions about the DAIDS Score Manual, see the SCORE FAQ page.
Please see the links below for DLP training related to topics in the SCORE Manual.
Related Training Courses on the DLP
| Name | Description and Audience |
|---|---|
| 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. |
| 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.
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| 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. |
| DAIDS Protocol Registration System (DPRS) | Required training to access the DPRS. Staff members who will use the DPRS to prepare, submit, and track protocol registration documents must take this training. |
| DAIDS Expedited Adverse Event (EAE) Reporting eLearning Course | Review of DAIDS Expedited Adverse Event Reporting process and the system (DAERS) used for reporting . Completion of training is required for access to the DAERS. Those who must use DAERS include Staff members listed as:
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| Essential Documents | This course covers the purpose of essential documents and how to accurately generate, complete, maintain, and/or submit them (to Institutional Review Boards/Ethics Committees, regulatory authorities, or DAIDS) during a clinical trial. |
| Good Clinical Laboratory Practice | This training describes the standards to be followed by laboratories that process or perform analysis or evaluation of clinical trial samples. Training is required for international clinical laboratory staff involved in specimen processing and testing. |
| 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. |
| Investigator of Record (IoR) Responsibilities | This course provides an overview of the primary responsibilities of the Investigator of Record (IoR), sometimes referred to as the Principal Investigator (PI), to successfully conduct clinical trials that are sponsored and/or supported by DAIDS. CRS Leader, IoR, Sub Investigator, or anyone designated IoR responsibilities should take this training. |
| Investigator of Record (IoR) Study Product Management | This course reviews the Investigator of Record’s study product management oversight responsibilities. CRS Leader, IoR, Sub Investigator, or anyone designated IoR responsibilities should take this training. |
| 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. |
| Source Documentation | This course covers the role that source documents and data play in clinical trials, explains how to apply the ALCOA-C principles and other Good Documentation Practice requirements, introduces the process of de-identification, and discusses how to analyze, correct, and prevent source documentation errors. |
| Protocol Registration: Policy and Manual Training | Overview of the DAIDS Protocol Registration Policy and Manual. It is highly recommended that staff members who will be working with site regulatory and protocol related documents take this training. |
| GCP/HSP Training Option: DAIDS eLearning | Duration of 4 hours, this course fulfills both the GCP and HSP requirement. |
| HSP Training Option: ACRP eLearning | Duration of 2.25 hours, this course ONLY fulfills the HSP requirement, NOT the GCP requirement. |