GCP Finding

All GCP Findings

This training product is crafted for those who are involved in conducting clinical trials, at sponsor or CRO or at the Investigator site. Find out 150 unique GCP findings which covers everything from the essentials to more specialized topics in conducting clinical trials. With more than 500 pages, our GCP finding module covers following topics:

a) Informed Consent (39 Unique GCP Findings – 147 pages)

b) Study Logs and Forms (31 Unique GCP Findings – 99 pages)

c) Case Report Form (28 Unique GCP Findings – 105 pages)

d) Source Documentation (27 Unique GCP Findings – 89 pages)

e) Protocol Compliance (11 Unique GCP Findings – 52 pages)

f) Ethics Committee (09 Unique GCP Findings – 35 pages)

g) Investigational Product (05 Unique GCP Findings – 11 pages)

FDA Warning Letters

This module is crafted for those who are involved in conducting clinical trials, at sponsor or CRO or at the Investigator site. There are nearly 1300 pages containing:

a) Clinical Investigator/Sponsor Investigator – 220 FDA Warning Letters

b) Institutional Review Board – 73 FDA Warning Letters

c) Sponsor/Monitor/Contract Research Organization – 53 FDA Warning Letters

Informed Consent

This training module covers one of the most critical  and ethical pillar of subjects rights under ambit of GCP. It includes 39 unique examples of Informed Consent Procedure, Informed Consent Form and related documents, transcriptional errors.

This module helps Investigator and site team to avoid compliance issues related to Informed consent procedure and documentation.

Logs and Forms

This training module has been designed to demonstrate the 31 unique findings related to logs and forms used in conducting clinical trials.

The documents used to provide training are:

1. Duty Delegation Log
2. Subject Identification Log
3. Subject Screening Log
4. Subject Enrolment Log
5. Temperature Log
6. IP Dispensing Log
7. IP Return and Compliance Log
8. Protocol Deviation Log

Source Documentation

One of the most common audit or inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data.

This training module focuses on the key principles of good documentation practice with 27 unique examples.

Case Report Form

Case Report Form is one of the most important tools for reporting/performing submission to the global regulatory bodies. And, it comes with inherent challenges due to transcription steps involves as data entries are being performed from various source documents, including prescriptions, study logs and forms, ECGs, laboratory reports, etc.

This training module has been designed to demonstrate 28 unique findings related to case report form.

Duty Delegation Log

This training module has been designed to demonstrate the findings related to one of the most important clinical trial document i.e. duty delegation log. The module demonstrate finding related to duties allocated to investigator and his/her site team through 14 unique examples.

Protocol Compliance

The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given approval/favourable opinion by the IRB/IEC.

Protocol non-compliance at clinical research sites is a well-recognized problem. This training module has been designed to demonstrate  protocol non compliance through 11 unique examples.

Investigational Product Compliance

This training product has been designed to demonstrate 19 unique findings related to Investigational Products used in conducting clinical trials.

This Investigational Product compliance training module emphasis on findings related to Investigational product Accountability, Dispensing, Storage, Use, Return & Compliance check.