Acronyms
PTCV
TIV
POSV
Other items
100
What does TCRA stand for?
Trial Clinical Research Associate- Not on every trial but often on larger trials
100
How many contracts must be fully signed prior to TIV?
The CML must be sure there are two fully executed contracts filed prior to any TIVs taking place
100
Is it true that the PI must attend an investigator meeting or other training set up by the CML prior to the CRA making a TIV?
Yes this is true, a TIV cannot be made without the PI having completed investigator meeting training
100
What document can the CRA follow on every POSV to ensure they complete all the activities required during a POSV?
POSV Explanatory Note
100
What is the name of the non profit group of pharma that have come together to standardize processes in clinical trials to facilitate the process for PIs who work with multiple companies?
TransCelerate
200
What does PTCV stand for?
Pre-trial Contact Visit
200
What does SFQ stand for?
Site Feasibility Questionnaire
200
Is it true that the CRAs must attend training on the monitoring manual and protocol in order to assume responsibility for assigned site(s)
This is true
200
What document can the CRA review to ensure they are following the correct monitoring schedule?
The monitoring manual
200
Does BI allow SI's to obtain Informed Consent?
Yes- if the SI is qualified they may perform IC and the PI must delegate this task on Trial Staff List
300
What does RDC stand for?
Remote Data Capture
300
Which group of people are responsible for collecting regulatory documents from the site and sending the Site Regulatory Document Tracking Form to the CML, Manager, & CRA via fax?
RDR group
300
Provide 2 pre-requisites needed prior to TIV taking place
Pre-requisites for TIV: Regulatory Document Review (RDR) Release occurs after: (Receipt of written IRB approval , necessary Essential documents have been received, reviewed, and accepted) Fully executed contract (signed by BI & PI) Confirmation of Training completion (Investigator / site staff) Trial materials at site (e.g. CRFs, trial database, lab equipment, demonstration kit for Investigational Medicinal Product (IMP), set up for RDC, & completed training Signed Monitoring Manual
300
Who provides supervision to the CRAs, provides trial training during the trial for the CRAs, & is a resource for CRA questions?
Manager
300
Within what timeframe should close out visits occur?
Typically within 3 months
400
What does LRDR stand for?
Lead Regulatory Document Reviewer
400
Name one essential document that is collected by the Regulatory Review Group?
Protocol Signature Sheet (requires wet ink signature) Protocol Amendment(s) Signature Sheet(s) Form 1572 CV(s) IRB Approval Letter for Trial IRB Membership Roster IRB Approval Informed Consent Form Laboratory License/Normal Values Financial Disclosure Medical License for PI HIPAA Advertisements (approved by clinical team)
400
List at least two items you should review prior to the TIV
Visit Preparation – Review the following information Protocol Review RDR Release Packet for documents that may need to be collected PTCV report CRA Satellite Site Checklist (if applicable) Source Data Status Report (includes EMR checklist) Laboratory Checklist ( if applicable) Explanatory Notes Monitoring Manual ISF Packet /CRFs AE Process TIV report or TIV checklist in MySites
400
Is it true that CRAs are checking to see that sites have received 7/15 SRs, follow up on open issues and action items, & write visit reports?
True- these are just some of the CRA activities on a POSV
400
Name the two distribution partners (DPs) utilized in the International Distribution Strategy (IDS) process
Almac & DHL
500
What does IIQ stand for ?
Initial Interest Questionnaire
500
Is the CRA responsible during the trial to collect essential documents from the site?
Yes during the trial the CRA will collect essential documents from the site
500
Who can approve the e-CRF pages in Remote Data Capture (RDC)?
The PI & SI
500
How quickly can a POSV occur once a subject is enrolled?
May occur within 10 days
500
What form does the site complete if they have IMP damaged during transport?
Product Device Compliant Form (PDCF)
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