ISF
Log that is required to be on site but not submitted to the sponsor.
What is the Subject Identification Log?
The PI is listed as attending the visit if they are talked to during this timeframe.
What is between the visit and the Report Approval?
The purpose of Source Data Review (SDR).
What is review for quality and compliance, identify unreported events and deviations?
The earliest point the MCRA can perform any study tasks.
When is after all available training is completed?
Documents that are related to the study and sent to the sites are filed in Veeva as ….
What are Relevant Communications?
This form needs to be signed if you are on-site to do training for Study A while monitoring study B.
What is the Sponsor Representative Visit Log for Study A and Study B?
Activity that should be completed shortly after the SQV.
What is send the SQV completion email to the study team?
A note to file may not be written by this person.
Who is the MCRA?
The MCRA escalates to the LMCRA and Monitoring Manager when these are triggered.
What are the study Key Risk Indicators (KRIs)
When writing a monitoring communication, it is important to use this type of language?
What is objective, soft, or factual?
The training material that should be provided to the site after the Site Initiation Visit
What is the SIV slide deck?
The monitoring technique that does not include SDV.
What is SRC Scheduled Remote Contact?
Investigational Product storage requirements.
Where is a secure area with limited access? (not with other commercial products)
The maximum time frame that a Follow-up Item may remain open without a commented.
What is 90 days?
Prior to closing the monitor queries, the MCRA ensures this.
What is ensures resolution is consistent with the SD?
This document is located in Veeva as the Site Signature Sheet
What is the SSRL?
Time frame for the monitoring event (IMV, COV, etc.) to be added to Veeva.
When is promptly? (Confirm the visit date in Veeva)
The safety events are reviewed at Closeout to determine this.
What is closure or resolution status?
Queries should not be written in this format.
What are leading or change required queries?
When a PI changes during the study, this study team member will initial the new PI start date.
Who is the new PI?
Insurance certificates are required at what time frame for international sites.
When is from ATE till end of study?
How a visit extension approval is filed by the MCRA.
What is attached to the MVR? (Add a note to comment section also)
These logs are collected at the Closeout Visit, name two.
What are?
Sponsor Representative Visit Log, SSRL, Screening & Enrollment Log, Device Accountability Log.
The best documentation practice when referring to a specific subject in a monitoring communication.
What is full subject ID as listed in the EDC?
The abbreviation GCO stands for this.
What is the Global Clinical Organization?