Regulatory
This is where you go to confirm the most current ICF for a study.
What is the IRB?
This step must be taken to ensure payment for on-site activities like monitoring visits, audits, and safety reports.
What is informing Cassidy via email or updating the implemented tracker?
This term refers to any untoward medical occurrence in a patient during a clinical trial, whether related to the IP or not.
What is an Adverse Event?
This step must be completed before scheduling a screening visit for a patient.
What is thorough prescreening?
This kind of protocol deviation occurs when a subject misses a scheduled visit.
What is a minor deviation?
The frequency with which a continuing review is required for a study.
What is 1 year?
You’ll find this in RT during the study build process to determine whether stipends are paid through RT PAY or a third-party system.
What are notes in RT and the stipend section value?
An event that results in death, is life-threatening, or requires hospitalization falls into this classification.
What is a Serious Adverse Event?
This individual is responsible for forwarding patient information for additional prescreening.
Who is Dalia?
A protocol deviation that affects subject safety or data integrity is classified this way.
What is a major deviation?
These forms do not need updating when a Sub-I leaves the study.
What is the 1572 and the FDF?
If a patient requests reimbursement for travel, this action should be taken before initiating any payments.
What is checking the subject receipt tracker and following the documented steps for requesting reimbursement?
SAEs typically must be reported to the sponsor and IRB within this timeframe?
What is 24 hours?
This team member conducts secondary prescreening to confirm patient eligibility for a screening visit.
Who is the Clinical Research Coordinator (CRC)?
Major protocol deviations must be reported to the IRB and Sponsor within this time period.
What is promptly or within 5 business days?
This document is NOT released through the IRB portal and must be obtained elswhere?
What is the protocol?
True or False: You should make your best guess and submit if you're unsure about entering visit data.
What is False? Always seek guidance—entries have financial consequences.
This individual is responsible for assessing the severity and causality of an AE or SAE.
Who is the Principal Investigator?
This service is offered to all patients for each of their study visits.
What is Uber?
Protocol deviations are typically documented in this section of trial records.
What is the deviation log or site notes?
Even if not deemed "important," all study correspondence must be filed here.
What is the Investigator Site File (ISF)?
True or False: You can wait to update a patient's enrollment status once SF/randomization is known since visit data has already been entered.
What is False? Status updates must happen as soon as they're known—they may impact sponsor billing.
Adverse Events are typically recorded in this section of the Case Report Form.
What is the Safety or Adverse Event Log.
Study visits, including consenting and assessments, must take place in this type of space.
What are designated exam rooms?
This is the best way to minimize protocol deviations before a study begins.
What is thorough site training and visit prepping?