Site Selection & Release
What needs to be signed before the CTM can release the SFQ to the site?
The Confidential Disclosure Agreement
What system do the ISP colleagues enter their daily activities in (i.e., Training, General Work, Trial activities, etc.)?
TimeRecorder
If you open a document with PHI on it, do you forward it to your CTM?
No! You never forward an unredacted document
Who is responsible for monitoring the sites to ensure that the trial is conducted according to ICH/GCP?
The CT Manager/MRA and CRA are responsible for monitoring the sites to ensure that the trial is conducted according to ICH/GCP
What is the timeline for getting Pregnancy Monitoring Forms in to GPV?
24 hours
Does the CT Manager have to confirm the SQV waiver?
Yes
What system do we enter trial activity only in?
Jpourmyx
If you receive a call from a wife of a subject who gives you her name, the subjects name, and tells you the subject was admitted to the hospital, would you give her name and the subjects name to the CTM when you share this information with them?
No! You would not give the wife's name nor the subject's name. You would only give the CTM the subject's number and state the wife called. You have to protect the PHI of the subject and his wife.
What visit reports must the CT Manager review within 5 days of receipt of the report from the CRAs?
The Site Qualifying Visit and the Site Initiation Visit reports.
What does AESI stand for?
Adverse Event of Special Interest
Do the CT Managers have to send a letter of acceptance to all PIs selected to participate in the trial?
Yes! The CT Manager has to send a letter of acceptance to all the PIs who are selected
What is the name of BI's portal system?
Clinergize
Today you open an envelope and there is a Site Enrollment Form in it with DOB and initials of patients on it. What would you do? (Give me one of the steps needed to be taken)
1. Send the sender a Written Notification asking them to send a redacted document. 2. Educate the sender on redaction. 3. Align with Clinical Trial team to evaluate the event for non-compliance and entry in BICTMS/GEM system 4. Notify the DPO 5. Destroy the unredacted document once you have in your possession a redacted document from the sender
What information has to be on every Site Contact?
The following should be captured in the body of a Site Contact:
•Trial and Site identification
•Date of contact
•Sponsor representative(s) involved
•Site staff member(s) involved
•Topic discussed (including outcome of discussion, if applicable)
Will the CA team redact the DOB and initials on Adverse Event Forms?
No! Remember Adverse Event reporting allows for broader PHI sharing
Does the CTM need to notify the Primary Investigators who are not chosen for the trial?
Yes!
What system do the PIs' enter electronic case report form (eCRF) information?
BRAVE
An MRA received an electronic document from the site with PHI on it so the MRA sent it back to the site indicating for them to send a redacted document. Did this MRA take the right action? If No, what is the right action?
The MRA should never forward a unredacted document to anyone not even the sender.
What CO role processes 1572s on behalf of the CT Managers?
The RDR. CT Managers and MRAs have to tell the RDR team of any updated 1572s received
What portion of BICTMS do the CT Managers/MRAs enter into? 1. My Sites 2. Progress 3. Reporting
Progress
Is the CT Manager responsible to submit documents needed for the IRB/IEC applications?
Yes the CT Manager is responsible to submit documents needed for the IRB/IEC application
What system do you into to complete your Learning Plan?
LOS
Do the CAs ever send written notification to the sites when they receive documents with PHI on them?
No! The CAs will reach out to the trial CTM/MRA and ask them to do all the steps on their behalf.
When do PIs have to complete Financial Disclosures?
Initially when first selected for a trial and then only if their financial status changes.
If a CRA enters No at a question on a Visit Report, will the CRA enter an Issue in Issue Management? True or False