Determines therapeutic benefit and usually done in a larger, specific population-
Phase 3
Therapeutic use begins, after drug approval-
Phase 4
Most typical studies investigate human pharmacology. Initial administration or investigational new drug into humans. Most common in healthy subjects.
Phase 1
Providing a unified standard for Europe, US and Japan to facilitate the acceptance of clinical trials
Mission statement of ICH
Investigator can be defined as-
- Responsible leader of clinical research team at the site, may be called principle investigator
- Person responsible for the conduct of the clinical trial at trial site
Sub-investigator defined as-
Any individual member of clinical research team designated and supervised by the investigator to perform trial-related procedures or to make trial related decisions
Sponsor defined as-
Individual or company, institution or organization which takes responsibility for initiation, management and/or financing of the trial
Essential documents defined as-
Documents which individually or collectively permit evaluation of the conduct of a study and the quality of data produced
Source data defined as-
All information in original records and certified copies of original records of critical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial
When should the contractual agreement between the sponsor and investigator be signed?
Before the trial
Which documents is the investigator obliged to comply with during the trial?
- ICH-GCP
- Trial protocol
- All applicable laws and regulations
What does the IRB/IEC evaluate?
- Scientific tenability of the trial
- Subject-selection procedure
- Rights, safety and well-being of the subjects participating in the trial
A potential investigator usually only receives a protocol and investigator brochure to review from a sponsor when?
After signing a confidentiality agreement
NOT a required element of an informed consent-
A listing of all site personnel who will be involved in the research
Which should the investigator do if an SAE occurs?
- Inform the sponsor immediately
- Inform IRB/IEC, if required
After an SAE occurs, how should a subject identification occur on the immediate and follow-up reports?
Subject identification number
In the event of a subject’s death, what additional information should be supplied to the sponsor?
- Terminal medical reports
- Autopsy report
What documentation should be supplied to the sponsor before the study?
- CVs of all investigators and other study personnel who are significantly involved in trial related duties
- Signed contract between sponsor and investigator
Who must sign an ICF?
- Subject with subject’s legal representative
- Person who conducted ICF interview
Which are required by the IRB/IEC before approval?
- Telephone script for patient recruitment
- Subject information leaflet
- Study protocol
What details need to be documented in the subject notes when an AE occurs?
- When the event occurred
- Severity of the event
Who is responsible for appropriate monitoring of clinical trials?
The sponsor
During the trial, who is responsible for communicating with the IRB/IEC?
The investigator
A candidate presents for a monitor position. What qualifications should the potential monitor be able to provide proof of to be considered?
- Be familiar with GCP
- Have clinical knowledge to monitor a trial
- Have scientific knowledge to monitor a trial
