independent learner course guide (Mar 2019) - CITI Program

GOOD CLINICAL PRACTICE (GCP) - CITI Program

CITI Program: Good Clinical Practice (Updated: January 2017) citiprogram.org 2 Table of Contents Basic Courses Page GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) 3 GCP for Clinical Trials with Investigational 10Drugs and Biologics (ICH Focus)

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The Belmont Report - CITI Program

guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees.

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FAQs on Regulatory Documentation for Clinical Research

BU/BMC Clinical Research Resources Office: FAQs on Regulatory Documentation for Clinical Research (2/1/10) p. 2 www.bumc.bu.edu/crro . 3) If my study is not a drug ...

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Investigator Initiated Study Dispatching SRD GROUP

Greetings & Company Profile SRD Co., Ltd. was established in 1989 as a company that specializes in supporting clinical research and development.

Role of IRB/IEC in GCP

Responsibilities of IRB/IEC Safeguard the rights, safety, and well-being of all trial subjects Review documents • Protocol/ amendments • Informed consent forms (ICF) • Subject recruitment procedures (advertisement) • Patient information sheet • Investigator’s Brochure • Payments for subjects • Investigator’s cv • Others Review protocols within a

  Protocol

Drug Development 1.2 Procedures for Clinical Trials

36 new routes of administration and new combination drugs, they must be submitte d at least 31 days before the planned start date of the trial stated in the contract

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Global Guideline for GCP Audit

Risk Management The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk.

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Guideline for the notification of serious breaches of ...

template . The completed comments form sh ould be sent to gcp@ema.europa.eu 8