General Knowledge

Question 1

What is the purpose of ICH-GCP in clinical research?

Answer 1

ICH-GCP sets a global ethical and scientific standard for clinical trials. It protects human subjects and ensures credible data collection.

Question 2

Who holds primary responsibility for GCP compliance during a trial?

Answer 2

The sponsor is ultimately accountable. However, investigators and CRAs ensure daily site-level adherence through monitoring and documentation.

Question 3

What role does the Institutional Review Board (IRB) or Ethics Committee play?

Answer 3

They review protocols, informed consent documents, and trial amendments to protect participant rights and safety.

Question 4

What are considered essential documents under GCP?

Answer 4

Documents such as trial protocol, CRFs, informed consent forms, investigator brochures, and monitoring visit logs are essential to demonstrate compliance.

Question 5

When is re-consent from a participant required?

Answer 5

Whenever there’s a significant protocol change, updated risk information, or new consent form version.

Question 6

What’s a common informed consent error seen during audits?

Answer 6

Using an outdated or unapproved consent form version or obtaining consent after initiating study procedures.

Question 7

How should protocol amendments be handled at the site level?

Answer 7

They must be approved by the IRB before implantation, unless immediate changed are required to eliminate safety hazards.

Question 8

What does a CRA check when reviewing consent documentation?

Answer 8

Proper signatures, accurate dating, version control, and assurance that no study procedure occurred before consent.

Question 9

What is source data verification (SVD) under GCP?

Answer 9

It is the process of comparing trial data entered into the CRF with the original medical records or source notes.

Question 10

Can a legally authorized representative (LAR) provide consent?

Answer 10

Yes, when the participant lacks decision-making capacity and if permitted by law and approved by the IRB.

Question 11

What is the Declaration of Helsinki?

Answer 11

A set of ethical principles developed by the World Medical Association guiding research involving human subjects.

Question 12

Are verbal consent allowed in clinical trials?

Answer 12

Only when IRB-approved and thoroughly documented, including a witness’s signature or recording as per protocol.

Question 13

When should protocol deviations be reported to the IRB?

Answer 13

Any deviation affecting participant safety, rights, or data integrity must be reported promptly, typically within 5-15 days depending on IRB policy.

Question 14

What’s the difference between a protocol amendment and a protocol deviation?

Answer 14

A protocol amendment is a planned change approved by the IRB before implementation. A deviation is an unplanned departure from the approved protocol.

Question 15

What must be included in a protocol deviation report?

Answer 15

Date, description of the deviation, subject ID (if applicable), impact on safety or data, and corrective/preventive actions.

Question 16

Who is responsible for ensuring protocol compliance at the site level?

Answer 16

The Principal Investigator (PI), supported by site staff and monitored by the CRA.

Question 17

When can a CRA permit protocol deviations?

Answer 17

Never. Only the IRB and sponsor can approve changes; CRAs must report and document any deviations found.

Question 18

What are common CRA finding related to protocol non-compliance?

Answer 18

Early dosing, missing labs, unreported adverse events, or unapproved consent versions.

Question 19

How often must IRB continuing reviews occur?

Answer 19

At least annually, though some high-risk studies may require more frequent reviews.

Question 20

What documents must be submitted to the IRB for multi-site trials?

Answer 20

Full protocol, investigator brochures, informed consent forms, recruitment materials, and PI credentials.

Question 21

What is the difference between a central IRB and local IRB?

Answer 21

Central IRBs review for multiple sites nationally; local IRBs serve individual institutions and may have stricter requirements.

Question 22

What happens if IRB approval lapses during a trial?

Answer 22

All study activities must stop until re-approval is obtained—except actions required for participant safety.

Question 23

What is a regulatory binder?

Answer 23

A site’s official storage of essential documents, including IRB approvals, protocol versions, investigator credentials, and monitoring logs.

Question 24

What is the 1572 form?

Answer 24

The Statement of Investigator form submitted to the FDA, outlining PI responsibilities and qualifications for IND trials.

Question 25

What is the difference between AE, SAE, and SUSAR?

Answer 25

AE (Adverse Event): Any untoward medical occurrence. SAE (Serious Adverse Event): Results in death, hospitalization, disability, or is life-threatening. SUSAR (Suspected Unexpected Serious Adverse Reaction): An SAE that’s unexpected and possibly related to the investigational product.

Question 26

Who is responsible for initial AE reporting at the site?

Answer 26

The site’s Principal Investigator.

Question 27

What AE documentation should be reviewed during monitoring?

Answer 27

Source documents, AE logs, progress notes, and CRF entries for consistency and timely reporting.

Question 28

What's the regulatory deadline for reporting SAEs to sponsors?

Answer 28

SAEs must be reported immediately, typically within 24 hours of site awareness

Question 29

When must a SUSAR be reported to reulators?

Answer 29

Fatal/life-threatening: within 7 days; others within15 days

Question 30

What does "relatedness" refer to in AE reporting?

Answer 30

Whether the event is causally linked to the investigational product. Assessed by the investigator.

Question 31

What defines an unreported AE?

Answer 31

An event documented in source files but missing from CRFs or AE logs.

Question 32

What triggers an unscheduled monitoring visit?

Answer 32

Frequent protocol deviations, data inconsistency, enrollment irregularities, or sponsor-initiated audit preparations.

Question 33

What must be in the regulatory binder?

Answer 33

IRB approvals, PI CV/license, protocol/amendments, AE logs, IP logs, delegation logs, and communication records.

Question 34

What is the purpose of the Case Report Form (CRF)?

Answer 34

The CRF captures all protocol-specified data for each participant. It ensures standardization, supports regulatory audits, and contributes to final study reporting.

Question 35

What's the difference between eCRF and paper CRF?

Answer 35

eCRFs are electronic and allow real-time data capture and query management. Paper CRFs require manual entry and are more prone to transcription errors.

Question 36

What is a deviation log?

Answer 36

A running list maintained at the site to track all protocol deviations, including date, subject ID, type of deviation, and resolution status.

Question 37

What is the purpose of a Delegations of Authority Log?

Answer 37

This document lists staff authorized to perform study tasks, with their start and end dates, signatures, and roles—critical for audit readiness.

Question 38

What does EDC stand for?

Answer 38

Electronic Data Capture—a centralized platform for entering and managing clinical data in real time.

Question 39

What is the focus of Phase I trials?

Answer 39

Phase I trials primarily assess safety, tolerability, dosage range, and pharmacokinetics. They’re usually conducted on small groups of healthy volunteers.

Question 40

What makes Phase I units unique?

Answer 40

They operate in controlled environments with continuous monitoring, focusing on adverse reactions and drug metabolism.

Question 41

What are Phase II trial objectives?

Answer 41

To evaluate drug efficacy in patients with the target condition, determine optimal dosing, and identify side effects.

Question 42

How are endpoints elected for Phase II?

Answer 42

Endpoints are typically clinical improvements, biomarker changes, or measurable symptom relief, aligned with study objectives.

Question 43

What is the ethical concern in placebo-controlled Phase II trials?

Answer 43

Ensuring equipoise—researchers must believe there’s genuine uncertainty about which treatment is better, and that patients aren't denied standard care.

Question 44

What distinguishes Phase III trials?

Answer 44

They involve large patient groups across multiple centers to confirm efficacy, monitor adverse effects, and support regulatory approval.

Question 45

How are recruitment targets managed in Phase III?

Answer 45

CRAs monitor site performance metrics, enrollment logs, and screen failure rates, and escalate lagging sites to sponsors.

Question 46

What documentation burden increases in Phase III?

Answer 46

Due to scale, Phase III demands higher volume of source documents, regulatory updates, IP tracking, and monitoring visit frequency.

Question 47

What is Phase IV?

Answer 47

Post-marketing studies assessing long-term safety, real-world effectiveness, and rare adverse events.

Question 48

What does long-term follow-up in Phase IV require?

Answer 48

Robust retention strategies, patient contact tracking, and remote or hybrid monitoring to ensure compliance over time.

Question 49

Are endpoints in Phase IV regulatory-driven?

Answer 49

Not always. Many endpoints are observational, economic, or patient-reported for real-world evidence gathering.

Question 50

What are the key risks in Phase IV?

Answer 50

Patient dropout, under-reporting of adverse events, and variability in practice standards across real-world sites.