Consent Curveballs
A potential participant has low vision but can read with magnification. Before moving forward, what must staff have them do?
Have them demonstrate reading ability by reading a line from the ICF. Use of a magnifying glass/accommodation is documented on FORM-CR-001.
A serious event occurs Monday, but the investigator does not learn of and assess it until Tuesday. According to the SOP, what starts the 24-hour sponsor-reporting timeframe?
The investigator’s knowledge and assessment of the SAE/AESI.
Assigned unmasking IP is being moved from temperature-controlled storage to the treatment room on a masked study. How should it be transported when applicable?
In an opaque container to maintain masking.
Before IP administration, two staff members have confirmed the kit number. That alone is not enough. Name the five minimum “correct” elements the SOP says to verify before administration.
Correct participant, medication, day/time, dose, and route/location.
A participant wants out of the study. Besides the reason for withdrawal, staff must separately clarify two decisions about what participation ends. What are they?
Whether withdrawal is immediate versus completion of safety/EOT/long-term follow-up activities, and whether optional consents are also being retained or withdrawn.
Before signing the ICF, the participant asks a question specifically about the medical aspects of the trial. Who must address the questions?
The PI or Sub-I must address the question.
When an AE is identified, the delegated investigator should determine seven key elements as soon as reasonably possible. Name at least five.
Any five of: AE medical term, start date, severity, attribution/causality, action taken with IP, medical care or medication given, and stop date.
Can the same investigator or staff member serve in both a masked and an unmasked role on the same study?
Yes. Cross-functional masked/unmasked roles may be assigned when supporting the study at more than one research location, with tasks and access limited to the role assigned at each site.
IP storage uses manual temperature documentation rather than retained continuous readings. At minimum, how often must delegated staff manually record the temperature?
At least once per day during business days, with records maintained in a central location.
A participant misses a scheduled study visit and stops responding. Before the site escalates the participant as potentially lost to follow-up, what is the minimum number of documented contact attempts required?
At least 3 documented contact attempts. The site should use available contact resources before escalating the LTFU process.
Does the SOP require the participant to receive the ICF before the day of their screening visit?
No. The ICF may be provided before the appointment or at the initial research visit, but the participant must be given adequate time to review/discuss it before the consent process proceeds.
For an SAE or AESI, the site needs to document exactly when it became aware of the event. Name two places where the date and time of site knowledge may be captured.
Any two of: medical chart, study source, telephone contact log, or Adverse Event Form.
A staff member serves as masked staff at Site A and unmasked staff at Site B. While working at Site A, what treatment-related information generated at Site A are they prohibited from accessing, reviewing, or discussing?
Treatment frequency, dosing, stratification assignment, and associated unmasking information.
A refrigerator excursion is identified. List the four pieces of information that must be communicated regarding the excursion.
Impacted IP, duration of the excursion, minimum/maximum temperature variation, and suspected root cause.
A participant asks for study-specific records that could expose masked treatment or confidential sponsor information. What should happen before the records are released?
Use discretion and consult RCA Research QA and/or the sponsor; redact masked, confidential, proprietary, or otherwise restricted information as appropriate.
An error is discovered on an already executed original ICF. Name the required documentation and three things that must happen after the error is identified.
Use the ICF Corrections Checklist; document the time, explanation, and corrective action; correct the original ICF; provide the corrected copy to the participant/LAR; and retain the corrected original with the checklist.
Additional information is needed to complete an SAE/AESI assessment. How many documented requests should be made, and what should happen if the information still cannot be obtained after a reasonable number of attempts?
At least three documented requests. If no additional information can be obtained, update the report to document that no additional information could be obtained.
You are working in the unmasked role at a site and are asked to review that site’s participant response assessments to help another masked coordinator. Are you allowed to review them?
No. Unmasked staff at that site must not access, review, or discuss participant progress information such as assessments supporting response or primary/secondary endpoints in order to maintain data integrity and objectivity.
A temperature excursion has occurred. What two quarantine actions must be taken with the affected IP to prevent it from being dispensed while sponsor determination is pending?
Quarantine it in the physical IP storage location and place it in quarantine within IRT, if applicable.
An FDA inspector arrives. What two inspection-specific items must be verified/presented before the inspection proceeds, and who receives the official notice?
Unexpired credentials documenting FDA association plus FDA Form 482. The Form 482 is given to the most responsible individual at the site.
During re-consent, do unchanged sections of the new ICF have to be reviewed in full again?
Every section is addressed. Unchanged sections may be verbally confirmed as unchanged from the previous version, while changed sections are reviewed in detail and documented on the ICF Checklist.
A participant dies and the site cannot obtain the death certificate or hospital death report after the required attempts. What are the next two actions permitted/required by the SOP?
Notify the sponsor, and public records may be used to confirm the death and date of death.
A masked coordinator accidentally sees treatment assignment. The protocol contains no specific instructions for the event. Name the SOP-required response elements.
Inform the sponsor/representative, report to appropriate/regulatory entities as required, document the reason for unmasking, and document corrective and preventive actions.
A participant returns unused self-administered IP, and the count does not match what should remain. Name the required site actions.
Document the returned IP count, retain the IP until reconciliation is complete, notify the sponsor/representative of the discrepancy, and file the related documentation/communication in the participant file.
A participant develops a medical emergency and the physician response is delayed. Name at least three actions site/clinic staff should or may take while awaiting physician response or the next level of care.
Any three: contact the onsite physician; call 911 if appropriate; obtain vital signs within staff qualifications; begin CPR if appropriate and qualified; retrieve the emergency supply kit; designate someone to document the event; remain with the patient when possible and do not leave them unattended.