List 4 things the CML has to ensure are done prior to letting TIV visits occur?
1. Have 2 fully executed contracts signed and filed in house
2. Have full regulatory document release (Final Fax)
3. Has signed Monitory Manual
4. Has signed "Site Release Form"
5. Has sent out the ISF
6. Has set up all accounts and passwords for sites
7. Has sent out all supplies
100
A CRA calls on Dr. Yellow's office and the PI, Dr. Yellow said he did not go to the Investigator Meeting. Can the CRA do the TIV?
No! The CRA cannot do a TIV if the PI has not had investigator training. The CRA would reach out to the CML and the CML would have to do 1:1 training. A CRA cannot make a TIV unless they see documentation of attendance to Investigator Meeting
100
What is RADAR?
Risk Assessment, Detection and Resolution (RADAR)
It is new method of remote monitoring endorsed by FDA
100
What form is utilized when there is a deviation in stored IMP at the site and the temperature deviation is either a significant or non significant change?
The Drug Storage Temperature Excursion Report and Assessment Form
If significant deviation a PDCF also must be completed
200
What group does a feasibility analyst belong to? CML, CMTTS, COS?
The COS group= Clinical Operations Support
200
What steps does the site take when obtaining informed consent? (Who signs & what actions does site do)
The site has subject sign ICF
The provider signs ICF
The site documents in medical record/source consent obtained
The site provides copy of ICF to the subject
200
At the investigator meeting will the PI learn about Adverse Event Reporting, RDC, & Temp Loggers?
Yes! The investigator meeting is a meeting to teach investigator about the compound, adverse event process, the RDC system, & temperature loggers.
200
What does COS stand for? What do they do?
Clinical Operations Support. They provide CMLs with pool of potential investigators
200
What are the two steps for POD of IMP?
Step 1: Someone signing for the box of drug
Step 2: Someone opening the box of drug & checking
temp logger downloading data & entering in IRT
that drug has arrived and is useable.
300
What is an IIQ? What is a SFQ & what is needed prior to sending a SFQ?
An initial interest questionnaire is used to get a sense of providers interest in doing a trial with BIPI. Ask broad questions nothing specific about the trial
Site Feasibility Questionnaire - must have CDA in house prior to letting COS group send out SFQ.
300
A SI signed a Financial Disclosure Form at start of trial. The same SI a month into the trial is going to become the PI for the trial. Does the SI have to complete another Financial Disclosure Form?
No! One and done unless they have a change in finances.
300
Who is responsible to provide Pre-Trial Contact Visit Training to the CRAs?
It is the CML's responsibility to plan a meeting to teach the CRAs prior to the PTCV.
300
What does CTSU stand for? What do they do?
Clinical Trial Supplies Unit. They provide the IMP to either sites directly or distribution partners for dissemination to the sites once the CML signes the Site Release Form
300
What form is completed and sent to CTSU when there is a temperature excursion during transportation
The Product Device/Complaint Form
400
Why would you need 3 CDAs if a PI is running three trials for BI?
CDAs are trial specific. The PI will sign 3 because each one will have a different trial number on it.
400
Who does the CML liaise with in the regulatory group to ensure their site has regulatory release?
hint: Same person that sends the final fax with regulatory release to the CML
The LRDR= The lead regulatory document reviewer
400
Who creates the ISF originally that is given to the CML to adapt on the local level?
The ISF is created on the trial level by the TCM. They utilize the Corporate ISF table of contents. The TCM then sends out to all OPUs (CMLs). The CML then will advise TCM if they need to adapt ISF for any reason locally.
400
What is DEDP? What form is filled out when this occurs?
What does AESI stand for?
Drug Exposure During Pregnancy. The Pregnancy Monitoring Form
Adverse Event of Special Interest
400
What form does the CML complete to release drug?
Site Release Form
500
What are the 4 criteria for PTCV Waiver?
The site has been visited by BI or BI rep within 12mo.
The site has no major personnel changes
The site is a good performer
The new trial is in the same therapeutic area as current trial PI is running
500
A CML has 2 fully executed contracts & regulatory document release but they do not have a signed monitoring manual, can they tell the CSMG to have the CRAs start trial initiation visits?
No! The CML must have a signed monitoring manual and also have signed the Site Release Form prior to allowing TIVs
500
Name two types of monitoring we utilize in BI to demonstrate oversight?
At BI we utilize:
Direct Contact
Remote Monitoring- Risk Based Monitoring
Periodic Onsite
Vendor Monitoring
500
What does CAPA stand for? When do the clinical teams do CAPAs?
Corrective Action Preventative Action. Whenever there is a critical or major non-compliance we do CAPAs
500
What are the two steps the CML must make sure are done prior to signing Site Release Form and giving green light to drug release?
Step1: Confirm that CTSU has had a QP or CSRO sign off on CoA and CoC.
Step2: Confirm CA & IEC approval obtained