Clinical Trials / GCP Trainings and Workshops

Clinical Trials / GCP Trainings and Workshops

GCP General Trainning

CCRB organizes clinical trial educational program by contract from time to time. The objectives of the workshops are to understand the basic principles of GCP, clinical trial management and clinical trial designs. The workshops further enhance the clinical research knowledge of the front line research staff including the investigators, study coordinators, research nurses and open to the pharmaceutical industry.

  1. GCP Workshop
    • Introduction to GCP
    • The Responsibility of Investigators
    • Delegation of Responsibilities
    • Interaction with Ethics Committee
    • Clinical Trials Operation
    • Standard Operating Procedures
    • Protocol Compliances
    • Informed Consent Process
    • Adverse Event Reporting
    • Study Drug Handling
    • Study Documentation and Record Keeping
  1. GCP Fundamental Course

    • Overview of GCP
    • Ethics Committee
    • Informed Consent
    • Serious Adverse Event
    • Clinical Trial Design and Protocol Development
    • Regulatory Requirements
    • Study Documentation
    • Data Handling and Record Keeping
    • Drug Accountability
    • Study Closure
    • Clinical Trial Monitoring
    • Clinical Trial Audit

 

Frequently Asked Questions After You think You “understand” GCP

Q1.     Can a study coordinator be the impartial witness for trial subjects?

Q2.     I am a clinical trials monitor. I found that one of the trial patients was overdosed. At the conclusion meeting of the monitoring visit, the Principal Investigator told me he delegated all trial related duties to his colleagues and he was therefore not responsible for the finding. Is it true?

Q3.     I am a clinical research coordinator. My trial patient was admitted to the hospital due to low serum Potassium. A SAE report was sent to the sponsor right after admission. He had a minor stroke after his serum Potassium resumed to normal on Day 2. The Investigator decided to keep the patient in the hospital for couple days more. Should the minor stroke be reported to the sponsor as a SAE?

Q4.     Are patients with incurable diseases or are subordinate hospital and laboratory personnel vulnerable subjects under ICH-GCP?

Q5.     Sponsors are asking for copies of the Principal Investigator’s and sub-Investigators’ medical licenses. Can the investigators refuse?

Q6.     Can clinical sites refuse monitoring and auditing by sponsor?

Q7.     Should the Principal Investigator maintain a list of appropriately qualified persons to whom he/she has delegated “responsibility”?

Q8.     Who is responsible for ensuring that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related dutiesand functions?

Q9.     I am the clinical research coordinator. A trial patient is admitted to our ward for medical care. The PI is currently on leave. Should I ask the sub-Investigator who is a qualified physician for medical care of the trial subject?

Q10.     Prior to IRB approval, can advertisements for trial patient recruitment be posted in clinical areas?

Q11.     Can investigator replace protocol required serum pregnancy tests with dip-stick pregnancy tests for trial patients without sponsor agreement and IRB approval?

Q12.     I am a clinical research coordinator. A trial patient asked me to put a date chop on the consent form for him. Can I do that?

Q13.     Can a proxy give consent, sign and date the written informed consent form to studies and collect tissue specimens for examining cellular structure of a cancer tumor?

Q14.     I am a clinical trials monitor. During the monitoring visit, I found a data discrepancy between the blood pressure value in the Case Report Form and the patient’s medical records. The site personnel changed the data on the medical records and then initialed and dated the changes. She told me the changes were made in accordance with ICH-GCP. Is it correct?

Q1.     Can a study coordinator be the impartial witness for trial subjects?
A1.     No. The impartial witness is a person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject (ICH-GCP 1.26).

Q2.     I am a clinical trials monitor. I found that one of the trial patients was overdosed. At the conclusion meeting of the monitoring visit, the Principal Investigator told me he delegated all trial related duties to his colleagues and he was therefore not responsible for the finding. Is it true?
A2.     No. The Principal Investigator is a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team (ICH-GCP 1.34).

Q3.     I am a clinical research coordinator. My trial patient was admitted to the hospital due to low serum Potassium. A SAE report was sent to the sponsor right after admission. He had a minor stroke after his serum Potassium resumed to normal on Day 2. The Investigator decided to keep the patient in the hospital for couple days more. Should the minor stroke be reported to the sponsor as a SAE?
A3.     Yes. The minor stroke requires prolongation of existing hospitalization. It should be reported to the sponsor as a SAE (ICH-GCP 1.50).

Q4.     Are patients with incurable diseases or are subordinate hospital and laboratory personnel vulnerable subjects under ICH-GCP?
A4.     Yes. (ICH-GCP 1.61).

Q5.     Sponsors are asking for copies of the Principal Investigator’s and sub-Investigators’ medical licenses. Can the investigators refuse?
A5.     No. The Investigator should provide evidence of his/her qualifications through an up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor (ICH-GCP 4.1.1).

Q6.     Can clinical sites refuse monitoring and auditing by sponsor?
A6.     No. Clinical sites should permit monitoring and auditing by the sponsor (ICH-GCP 4.1.4).

Q7.     Should the Principal Investigator maintain a list of appropriately qualified persons to whom he/she has delegated “responsibility”?
A7.     No. The Principal Investigator should maintain a list of appropriately qualified persons to whom he/she has delegated “significant trial-related duties”; not “responsibility” (ICH-GCP 4.1.5).

Q8.     Who is responsible for ensuring that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related dutiesand functions?
A8.     The Investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and function (ICH-GCP 4.2.4).

Q9.     I am the clinical research coordinator. A trial patient is admitted to our ward for medical care. The PI is currently on leave. Should I ask the sub-Investigator who is a qualified physician for medical care of the trial subject?
A9.     Yes. A qualified physician, who is an Investigator or a sub-Investigator for the trial, should be responsible for all trial-related medical decisions (ICH-GCP 4.3.1).

Q10.     Prior to IRB approval, can advertisements for trial patient recruitment be posted in clinical areas?
A10.     No. Before a trial can be initiated, the investigator/institution should have written and dated approval from the IRB. Therefore all subject recruitment procedures (e.g., advertisements) should not commence until IRB approval is opbtained (ICH-GCP 4.4.1).

Q11.     Can investigator replace protocol required serum pregnancy tests with dip-stick pregnancy tests for trial patients without sponsor agreement and IRB approval?
A11.     No. The Investigator should not implement any deviation from, or changes to the protocol without agreement by the sponsor and prior to IRB approval (ICH-GCP 4.5.2).

Q12.     I am a clinical research coordinator. A trial patient asked me to put a date chop on the consent form for him. Can I do that?
A12.     No. The written informed consent form should be signed and personally dated by the subject (ICH-GCP 4.8.8).

Q13.     Can a proxy give consent, sign and date the written informed consent form to studies and collect tissue specimens for examining cellular structure of a cancer tumor?
A13.     No, except under the conditions provided in ICH-GCP 4.8.14,a non-therapeutic trial (i.e. a trial in which there is no anticipated direct clinical benefit to the subject) should be conducted in subjects who personally give consent and who sign and date the written informed consent form (ICH-GCP 4.8.13).

Q14.     I am a clinical trials monitor. During the monitoring visit, I found a data discrepancy between the blood pressure value in the Case Report Form and the patient’s medical records. The site personnel changed the data on the medical records and then initialed and dated the changes. She told me the changes were made in accordance with ICH-GCP. Is it correct?
A14.     No. The change or correction to a “CRF” (not medical records) should be dated, initialed, and explained (if necessary) (ICH-GCP 4.9.3). Medical records are classified as original documents (Source Documents – ICH-GCP 1.52) and should never be changed retrospectively.