Offering Category: Are you a study coordinator or team member seeking resources and support?

A guide to ensure clinical research is conducted safely and accurately by documenting clear roles and responsibilities for each member of the team

A guide to the consent process ensuring compliance with IRBMED, FDA, ICH GCP, and specific sponsor requirements

Strategies to embed compliance in your team operations, optimize communication with participants and address study deviations to safeguard research integrity

Guide to ensure accuracy and safety in your clinical trials with vigilant equipment management, all documented for ready verification and adherence to protocol standards

Study-specific, local, and federal guidelines for AEs, SAEs, UADEs, and Unanticipated Problems to maintain regulatory congruence and integrity in research practice

A guide to tailor internal audits to the study’s context and history, documenting all resolutions for continuous improvement and adherence to ethical, safe, and high-quality research protocols

A guide for diligent management of IRB applications and reporting obligations through meticulous documentation and tracking of responsibilities

A process for the preparation, review, implementation and retirement of an SPG

Traceable Case Report Forms crafted to connect each data point back to its origin, ensuring data integrity

Delineates the systematic storage, tracking and retrieval of clinical research records