ALCOA
Is the PI obligated to attend a remote monitoring visit?
No - It is recommended that the PI attend but it is but it is not an obligation per SOP-CDS-11 v0
How long does a site have to report an SAE from the time of awareness?
24 hours
What document outlines the design, describes the objectives, methodology and overall organization of a study?
Protocol
Expenses can be submitted in other currencies. T/F?
False - all expenses must be submitted in USD
What do you do to empty spaces on a log?
Cross out empty spaces, initial and date
Sponsor approval is not needed for an SIV to occur if IP will not be onsite at the time of the visit. T/F?
False - Sponsor approval is needed. The CRA should confirm that the Sponsor has approved the SIV to move forward and document the actions taken and filed in the TMF per SOP-CDS-003
Any untoward medical occurrence to a patient given a pharmaceutical product and that at any dose; leads to death, hospitalization, birth defects, disability or is life threatening
Serious Adverse Event
Are sites required to record vitamins/supplements as conmeds?
Yes, any drugs taken other than the study IP is considered a conmed
What is the timeline for submitting an expense report?
Within 7 days of returning from your trip
Is using whiteout acceptable?
Using whiteout or blinding an error is not an acceptable form of correction and should be avoided to maintain transparency
What should a CRA do if an onsite SEV is waived?
Per SOP-CDS-002, CRAs are to complete a SEV Waiver Form to be reviewed by the CTL or PM and approved by the sponsor. The signed SEV Waiver form should be filed in the TMF.
What does SUSAR stand for?
Suspected Unexpected Serious Adverse Reaction
A new Sub-I joins the study team. What regulatory documents should the CRA review during the next visit?
FDA 1572, FDF, CV, ML, GCP certificate, sponsor-specific protocol training and EDC training
No - you can only report expenses for one project within one expense report
Should you dispose of a sticky note used to record vitals?
No - Every originally captured piece of data must be retained, rather than replaced or deleted.
Per SOP-CDS-003, what are some of the general tasks a CRA should review during an SIV?
Collection of outstanding regulatory documents
Review site recruitment plan
Verify the adequacy of the site personnel, equipment and facilities
Review the Site Staff Delegation & Signature Log
Provide the SIV checklist to the site
Sign the Site Visit Log
What constitutes an SAE?
Death, Hospitalization/ prolongation of existing hospitalization, Birth defects, Disability, Life threatening, Investigator/Sponsor discretion
Following a Protocol Amendment/ IB Update/ICF update, what should a CRA do at their next visit?
Review the new IRB-approved ICFs and ensure all subjects are properly consented with the new ICFs
Travel-related expenses related to a client do not need a project ID. T/F
False - All client travel-related expenses should have a project ID assigned on the expense report. You can obtain the project ID from your PM.
What are the new letters that have been added to ALCOA?
ALCOACCEA
Attributable, Legible, Contemporaneous, Original, Accurate, Consistent, Enduring and Available
Per SOP CDS-007, what is the minimum information needed to start the SAE clock?
An identifiable patient
A suspect investigational product
An identifiable reportable source
An identifiable event or outcome that is serious
What is the timeline for reporting a fatal or life-threatening Adverse Drug Reaction?
ASAP but no later than 7 calendar days followed by a report within an additional 8 calendar days
How do you calculate study drug compliance?
Number of pills taken/ Total pills that should have been taken x 100
What category should you select when an expense is billable to a client?
Categories starting with "PT"