ICF quick quiz

Which is the last documents should be received before GLG process?

Select all applicable answers.

• Training record

• Protocol amendment acceptance form

• Approval letter

• Stamped ICF

How to track ICFs for each patients in CTMS?

• iCover

• Subject tab

• ICF list tab

• Documents tab

How to update new ICFs in CTMS?

• iCover

• Subject tab

• ICF list tab

• Documents tab

Before reconsenting for new version of ICF, which should be the last process to be completed? (Best Practice)

• CREC approval

• LEC approval

• Green Light Go submission

• Green Light Go approval

If the protocol and ICF amendment has been reviewed by expedited reviewing, which document did not need for GLG approval process?

• EC submission letter

• EC approval letter

• EC composition

• Stamped ICF

Normally, which patients did not need to be reconsented?

• Patients in treatment phase

• Patients in SFU phase

• Withdrawal patients

• Death patients

Which point in the ICF should be verified?

• ICF version

• Signature

• Date

• Number of subject

When should patient sign "Consent for treatment beyond progression"

• At first time when performed first consent

•  At the time when ICF was amended  

• At the time when the patient was diagnosed as PD  

• At the time when the patient want to sign

If female partner of male subject had pregnant. Which ICF should be signed by the female partner?

• Optional biopsies ICF

• Optional RBR ICF

• PPA ICF

• IAF ICF

Who should sign in the IAF ICF?

• Male participant

• Pregnant female partner of male participant

• Female participant

• Infant