Oncology Clinical Research Flashcards

Flashcards based on a mock job interview transcript focusing on oncology and clinical research.

Progression Free Survival

To slow down the progression of cancer, aiming to delay the advancement of the disease.

Stable Disease

To achieve a state where the disease is not progressing; remaining in a stable condition.

RECIST Criteria

Assessment criteria used to determine and classify disease progression, stability, or response in cancer studies.

Progressive Disease Definition

A twenty percent increase in the total tumor burden plus an absolute increase of five millimeters, or the presence of a new lesion.

Oncology Endpoints

Survival rate, complete or partial response rate, and time to progression.

Investigator Brochure (IB)

Details preclinical and clinical studies, safety data, and biochemical components of the investigational product (IP).

Purpose of Investigator Brochure

A document to educate the principal investigator on all aspects and characteristics of the IP.

Reference Safety Information (RSI)

Lists the expected adverse events associated with the IP, used to define if an event needs expedited reporting to regulatory agencies as a SUSAR.

Collaboration with Pharmacovigilance

Ensuring the EDC and safety databases are up to date with the same information, coding AEs and SAEs correctly using MEDRA coding, and reporting SAEs.

Data Review Plan

A plan outlining the data review process, frequency, and the data sets to be reviewed, including patient history, medications, and primary/secondary endpoints.

Medical Director

A clinical lead who collaborates closely with clinical scientists for site management and education, and answering investigator questions.

Staying Organized on Projects

Understanding study milestones, prioritizing tasks, and delegating to team members for faster progress.

Pharmacy Manual

Documents pertaining to the characteristics of the IP and instructions for its day-to-day administration, dispensing, and collection.

VIVA

System used for the management and storage of SOPs.

JReview

A software utilized as a data review dashboard to analyze data.