Course for Investigators and Study Team Members

Certificate of Completion

This is to certify that

First & Last Name

on (date)

participated in

ICH GCP

Course for Investigators and Study Team Members

The course was successfully completed

______

Dr Paweł Dyras – General Manager

Brillance, (place & date)

Stationary training:______

Duration: 8 hours

Trainer:______

Pursuant to the 124/KKM/2015 resolution of the Regional Medical Chamber Bureau in Cracow Brillance Ltd. is registered

as the subject authorized to conduct postgraduate education for Doctors and Doctors of Medical Dentistry under number

57-000117-003-0001. Abovementioned medical course is not covered by the ongoing specialization program or acquired ability

and it is awarded 1 point per 1 hour.

Final score for course completion: 8 points.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

The course has been accredited by the Association for Good Clinical Practice in Poland

ICH GCP

Course for Investigators and Study Team Members

1. History of Clinical Trials

2. Clinical Trials regulations

·  Nuremberg Code

·  Declaration of Helsinki

·  ICH

·  ICH GCP

3. General information on drug development phases and types of research with human subjects

4. Responsibilities in clinical trials

a) Sponsor’s responsibilities

b) Clinical Research Associate’s responsibilities

b) Investigator’s responsibilities:

·  Investigator’s qualifications and adequate resources

·  Medical Care of Trial Subjects

·  Contact with Ethics Committees

·  Compliance with Protocol

·  Investigational Product

·  Randomization procedures and unblinding

·  Records and reports

·  Informed Consent of Trial Subjects

5.Adverse events

·  Safety in clinical trials

·  Definitions

·  Reporting requirements

6. Site selection criteria

7. Documents in Clinical Trials

·  Study Protocol

·  Investigator Brochure

·  Informed Consent Form

·  CRF

·  Reports and records

·  Other documents

8. Audit- Clinical Trial control

9. Source documentation - management and filing

10. Final test