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GCP - Glossary

8 important questions on GCP - Glossary

Interim clinical trial/study report

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.

Legally acceptable representative

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.

Opinion (in relation to independent ethics committee)

The judgement and/or the advice provided by an Independent Ethics Committee (IEC).

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening,
- requires inpatient hospitalization or prolongation of existing hospitalization,
- results in persistent or significant disability/incapacity, or

- is a congenital anomaly/birth defect

Standard Operating Procedures (SOP)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

Validation of Computerized Systems

A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

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Clinical drug research

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GCP - Glossary

8 important questions on GCP - Glossary

Interim clinical trial/study report

Legally acceptable representative

Opinion (in relation to independent ethics committee)

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Standard Operating Procedures (SOP)

Subject Identification Code

Unexpected Adverse Drug Reaction

Validation of Computerized Systems

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