Site Setup
The purpose of the Site Setup stop to ensure that a clinical research site is ready to conduct a clinical trial.
Description
Clinical trial site setup involves a number of tasks, including:
- Providing training: Clinical research staff must be trained on the protocol and all procedures for the clinical trial.
- Providing supplies: Clinical research sites must be equipped with the necessary supplies to conduct the clinical trial.
- Establishing a quality assurance program: Clinical research sites must establish a quality assurance program to ensure that the clinical trial is conducted in a compliant and ethical manner.
DCT-specific Considerations/Inputs
DCTs may be conducted at a combination of traditional and alternative site locations. The nature and extent of training required will depend on trial specific processes and assessments, and who will be conducting them. Recommend documenting workflows for key processes identifying roles and responsibilities for site staff and local providers.
This includes training on any new study management and or data collection platforms, patient engagement tools, remote monitoring or wearable devices used to collect data.
- Create standards to provide and document appropriate staff training
- What is reviewed, queried and verified by whom? What is reviewed and unchanged?
- Technology and Data Strategy
- DCT Curriculum
- Data flow diagrams
- GDPR and other restrictions on data transfer and manipulation - pertains to PII and PHI and all associated trial data
- Data Connectivity
Regulatory Documents
FDA/U.S.
21 CFR Part 312 Investigational New Drug Application
ViewHealth Information Portability and Accountability Act (HIPAA)
ViewU.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024
ViewU.S. FDA Draft Guidance Document: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
ViewEurope/EMA
European Medicines Agency Recommendation Paper on Decentralised Element in Clinical Trials Version 01, 13 December 2022
ViewThe Principles of ICH GCP, Integrated Addendum to ICH R6(R1): Guideline for Good Clinical Practice ICH E6(R2) Section 2.7 ,2.8
ViewINVESTIGATOR: ICH E6 (R2) Good clinical practice (Sections 4.15, 4.2.5, 4.2.6)
ViewGeneral Data Protection Regulation
ViewReference Documents
JMIR - Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study
View