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A PATIENT File (PF) contains the demographic DATA, Medical and TREATMENT data about a patient or subject. It can contain PAPER records or can be a mixture of both paper and computer records

A Patient File (PF) contains the demographic data, Medical and treatment data about a patient or subject. It can contain paper records or can be a mixture of both paper and computer records

A Placebo is an INACTIVE pill, powder, liquid which contains no active AGENT. The use of a Placebo helps the researcher to ISOLATE the EFFECT of the STUDY treatment.

A Placebo is an inactive pill, powder, liquid which contains no active agent. The use of a Placebo helps the researcher to isolate the effect of the study treatment.

MASKING/ Blinding is NECESSARY because it eliminates any bias in the TREATMENT PROCESS being investigated.

Masking/ Blinding is necessary because it eliminates any bias in the treatment process being investigated.

Masking or BLINDING is the process of hiding the details weather the RESEARCH subject is receiving the Investigational product or a placebo or the current standard treatment

• Single Blinding: the subject doesn’t KNOW about the treatment
• Double Blinding: Both the researcher and the patient do not know about the treatment

Masking or blinding is the process of hiding the details weather the research subject is receiving the Investigational product or a placebo or the current standard treatment

INCLUSION & EXCLUSION CRITERIA are important in that the subjects are EITHER included in or excluded from a trial BASED on the inclusion and exclusion criteria.

Inclusion & exclusion criteria are important in that the subjects are either included in or excluded from a trial based on the inclusion and exclusion criteria.

During the TRIAL, the agent being TESTED is called an IND(INVESTIGATIONAL NEW DRUG).

During the trial, the agent being tested is called an IND(Investigational New Drug).

The DRUGS which did not UNDERGO CLINICAL Trial are called UNAPPROVED Therapeutic GOODS.

The Drugs which did not undergo Clinical Trial are called Unapproved Therapeutic Goods.

CLINICAL Trials are the comparative STUDY of Medication against the patient’s HEALTH condition.

A more comprehensive DEFINITION according to ICH is:

Any investigation in human subjects INTENDED to discover or verify the clinical, pharmacological and/or other Pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy.

Clinical Trials are the comparative study of Medication against the patient’s health condition.

A more comprehensive definition according to ICH is:

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other Pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy.

CLINICAL RESEARCH, Clinical STUDY, MEDICAL Research

Clinical Research, Clinical Study, Medical Research

JAMES LIND

James Lind

As a CD Manager, I can assure you of accurate, complete,consistent data for REPORTING, to the regulatory bodies. I also COMMUNICATE & coordinate with the PROJECT Manager, STATISTICIAN, CRA, DB Manager at the clinical sites as needed to ensure the accuracy and COMPLETENESS of the CT data.

As a CD Manager, I can assure you of accurate, complete,consistent data for reporting, to the regulatory bodies. I also communicate & coordinate with the Project Manager, Statistician, CRA, DB Manager at the clinical sites as needed to ensure the accuracy and completeness of the CT data.