PPD NOTES

Unblinding

: A procedure in which one or more parties to the trial are made aware of the treatment assignment(s) or IP type. Blinding is used in the design of some trials and other research studies to try to eliminate the bias of expectation influencing the research findings.

Clinical Trial Management System (CTMS)

software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.

Sub Investigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

Blinding

Blinding: A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double blinding usually refers to the subject(s), investigator(s), monitor and those involved in study conduct being unaware of the treatment assignment(s).

blinded study

Clinical trial in which the patient (single-blind) or patient and investigator (double-blind) are unaware of which treatment the patient receives. Involves use of multiple treatment groups such as other active, placebo or alternate dose groups. Sometimes referred to as "masked. try to eliminate the bias of expectation influencing the research findings.

Intended Unblinding

Unblinding events that can be expected to occur in clinical research (e.g., emergency unblinding at the investigator site, submission of unblinded safety reports to regulatory authorities, laboratory alerts, and Clinical Study Report (CSR).

Randomization

objects or individuals are randomly assigned (by chance) to an experimental group. Using randomization is the most reliable method of creating homogeneous treatment groups, without involving any potential biases or judgments.

Unblinded Study

A type of study in which that subjects are advised of all aspects of the study.

Partial Unblinding

Information that, when coupled with one or more pieces of data, may result in the unblinding of a subject's treatment, or knowledge that a group of subjects are on the same treatment arm or IP (Investigational Product) type (e.g., discovering that certain vials/bottles/etc. are placebo).

Roles that can transfer

Principal Investigator (VIP)*** Sub-Investigator Primary Coordinator Study Coordinator Pharmacist

(PM) Project Manager

Reports to, and receives instructions from, the Medical Affairs Director (MAD),Supervises and coaches the (1) Clinical Trial Manager, and the (2) Clinical Data Manager, Conceptualizes and designs protocol(s) for clinical trial(s), supportive of the sales and marketing of product(s), in coordination and consultation with the Brand Manager, Assists the MAD in monitoring all ongoing clinical projects, Delivers lectures to Sales Representatives on how to effectively use results of clinical trial(s), Proposes budgetary allocation for each and every clinical project to the MAD, Represents the MAD in meetings called for by medical societies, and clinical trial investigators.

(CTM) Clinical Trial Manger

Supervises and coaches the Clinical Data Manager and Clinical Research Associate, Implements and monitors clinical trials which have been approved by management, Periodically visits clinical trial investigators and provides them with their needs, such as Case Report Forms (CRF), drug samples, and stipends, Collects CRFs and checks their completeness and accuracy, Assists clinical trial investigators in writing the final technical report

System Project Manager

The IVRS team member assigned to a study-specific system responsible for IRT project management.

(PA) Project Assistant

They are responsible for providing support, status updates, and reports to supervisory project leaders while overseeing daily operational tasks associated with conducting the clinical study.

(CRA) Clinical research Assistant

Work in administrative positions. Depending on the setting and the trial, some CRAs might have also basic medical duties such as taking blood or performing lab tests. Health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.Depending on the jurisdiction, different education and certification requirements may be necessary to practice as a clinical research associate

Study Coordinator

a person responsible for conducting clinical trials using good clinical practice (GCP) facilitating, supporting and coordinating daily clinical research study activities, under the auspices of a Principal Investigator (PI)

sponsor

an individual, institution, company or organization (for example, a contract research organization) that takes the responsibility to initiate, manage or finance the clinical trial, but does not actually conduct the investigation.

Pharmacist

basic pharmaceutical sciences, including the development and testing of new dosage forms or medication-administration modalities, clinical research concerning the efficacy, safety, and pharmacokinetics of drugs, pharmacy practice research addressing various issues such as the evaluation of new and existing services, workload measurement, pharmacoeconomic, and quality management

Principal investigator (PI)

is the holder of an independent grant administered by a university and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for "head of the laboratory" or "research group leader."