Comprehensive training, organizational contacts, and meticulous hosting protocols for FDA inspections
Keyword: Standard Practice Guidelines
MICHR’s strategic approach to recruiting, screening, and enrolling participants in clinical trials
A guide to developing a clinical trial protocol which will stand as the cornerstone of as study, setting out the essential procedures and compliance standards
Principal Investigator (PI) Oversight / Staff Roles and Responsibilities Standard Practice Guideline
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 process for the preparation, review, implementation and retirement of an SPG