Which are the sections of ICH GCP?
See WHO GCP Principles 1: Ethical Conduct; 2: Protocol; 4: Benefit- Risk Assessment; 5: Review by IEC/IRC; 7: Informed Consent; 8: Con- tinuing Review/Ongoing Benefit-Risk Assessment; 11: Records; 12: Confidentiality/Privacy.
Which chapter of ICH GCP are essential documents listed?
GCP guidelines list the essential documents (ICH GCP E6 Section 8) that, at a minimum, must be maintained for every clinical study. These documents are to be maintained by the site and the sponsor, and are classified according to the stage of a study at which they are normally created.
How many sections are there in ICH GCP?
There are 13 core principles of ICH-GCP and they are as follows: 1. Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
Which SOPs are required by GCP?
Common SOPs
- GCP Training.
- Authority and Delegations of Responsibilities of Research Staff.
- Subject Screening and Recruitment.
- Informed Consent Process and Documentation.
- Eligibility Confirmation.
- Source Documentation.
- Data Management.
- Protocol Deviations.
What does ICH GCP section 2.10 say?
ICH GCP Section 2.10 states “all clinical trial information should be recorded, handled and stored in a way that allows its accurate recording, interpretation and verification”. This may be necessary in the event of unexpected side effects after the trial drug has been approved.
How is clinical trial information recorded in ICH GCP?
ICH GCP Section 2.10 states“all clinical trial information should be recorded, handled and stored in a way that allows its accurate recording, interpretation and verification”. This may be necessary in the event of unexpected side effects after the trial drug has been approved.
Is there an addendum to ICH E6 for good clinical practice?
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2018
What are the SOPs for the conduct of clinical research?
SOP Manual for Compliance with International Conference on Harmonization (ICH) Good Clinical Practice Guidelines and FDA Regulations at the Investigative Site Community Health Network Office of Research Administration SOPs for the Conduct of Clinical Research