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

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.

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

  Clinical, Procedures, Trail, Procedures for clinical trials

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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independent learner course guide (Mar 2019) - CITI Program

CITI Program: Independent Learner (Updated: March 2019) citiprogram.org 1 INDEPENDENT LEARNER Course Guide CITI Program’s independent learner courses and webinars are intended to provide access to

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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