Operations
Before enrolling a subject, the coordinator must confirm that they meet these requirements outlined in the protocol.
The eligibility criteria
This essential log documents who is authorized to perform trial-related duties and is signed by the PI.
The DAL (Delegation of Authority Log)
An adverse event that results in death, hospitalization, disability, or birth defect is classified as this.
An SAE
After an amendment is approved, all study staff must complete this step before working on the study
Complete protocol training
This essential document must be signed before any study-related activities, procedures, or data collection can occur.
If the protocol does not permit the access of a non-patient subjects EMR, how can you register them in OnCore?
Via a Generated "Dummy" MRN
Under the Common Rule, IRBs must conduct this type of review at least annually, unless criteria for exemption apply.
A Continuing Review (Annual Renewal)
What does "ALCOA" stand for?
Attributable, Legible, Contemporaneous, Original, and Accurate
How often do GCP and HSPP certificates expire?
Every 3 Years
This 1979 report established three guiding ethical principles for human subjects research: respect for persons, beneficence, and justice.
The Belmont Report
True or False: Minor deviations that do not impact subject safety or data integrity never need to be documented.
False
This regulation (21 CFR Part 11) sets requirements for the use of these in research.
Electronic records and electronic signatures
This acronym in clinical research stands for this, and it is used to collect protocol-required data.
“CRF” (Case Report Form)
How often does GeriOnc staff quality check all expiring credentials?
Quarterly
Per SOP5, essential documents must be retained for at least this long on site after official IRB closure.
2 Years
A subject’s eligibility was confirmed at screening, but by the baseline visit, they develop a new condition that violates an exclusion criterion. What is the FIRST step the the coordinator should do?
Inform the PI
True or False: A site can begin using a newly approved protocol amendment immediately if the sponsor says it’s okay, even before IRB approval.
False
Per SOP7, all intervention research studies in GeriOnc will have these made for them by the Data Control Team to help with consistent EDC management.
EDC Guidelines
Due to eREG, this document is no longer being used in the credentialing process.
DAL Profile Page
These three steps, at a minimum, should be taken by the coordinator to fully document a subject who is deemed LTFU.
(1) Write the NTF (2) Complete the CSF and (3) Update OnCore
During consent, a participant appears uncomfortable declining, and staff unintentionally imply negative consequences for not enrolling. What is this called?
Coercion
Under University of Rochester (UR) policy, which specific types of research events must be reported to the RSRB as Reportable New Information (RNI)?
Unanticipated problems involving risks to subjects or others, serious or continuing non-compliance, and suspensions or terminations of research
It is discovered that one staff member is consistently backdating forms to match data entry. What five steps should be taken to maintain data integrity and GCP compliance?
(1) Stop backdating immediately (2) Notify the PI (3) Document all instances (4) Write a NTF with a preventative action plan (5) File all documentation in the regulatory binder?
All Managers and Coordinators complete this type of training in eREG
Regulatory Coordinator - WCI
A subject travels to Florida for the winter and experiences a heart attack at a local hospital there. They tell us this when they return and compete a study visit. The hospital refuses to provide records. What do you do?
Tell the PI, document all attempts to obtain the records, and document the AE as best you can.