MRA ICF/Trial Start Up Jeopardy

Informed Consent

100

Is there ever an instance when BI allows for verbal consent over the phone?

Yes

200

What form is the CML encouraged to utilize when obtaining IC?

What is Trial Participant Re-Consent Form

300

Who must approve verbal consent?

The TCM & IRB/IEC

400

Is it true that patients even when doing verbal consent must be given time to ask questions?

Yes

500

Why is obtaining Re-Consent so important?

Because it shows that the patient wishes to continue to participate in the trial

Informed Consent

100

Is it true or false that there is a new Pre-Notification letter/email which the CMLs will utilize to prepare the sites that a re-consent is coming?

This is true

200

With the new Corporate SOP Informed Consent in Clinical Trials is it true or false that the CML/CRA must educate the sites of changes in new ICF, document it in the ISF, & document in EDMS?

This is true

300

Who is responsible to follow up from a monitoring perspective and ensure all the subjects are re-consented as directed by the CML?

The CRA

400

Is there specific documentation that the CML/CRA must teach the sites to document around verbal consent?

Yes very specific documentation is required

500

If verbal consent was allowed for a subject & the ICF was sent to the subject they signed it and sent to site. What happens when the subject comes in for the 1Visit?

The subject re-signs the ICF and the person who obtained the original informed consent signs & dates the original ICF again with the site staff who obtained the original verbal consent

Trial Start Up

100

How many contracts must be in house signed by both the PI & BI prior to trial initiation?

2 signed contracts in house= Fully Executed Contract

200

Name one thing that the CMLs must ensure is in place before trial initiation visit?

Fully executed contract, regulatory document release, Release of Drug, Monitoring Manual Signed, trial equipment is at site, sites have access to systems & system training they need

300

What does LRDR

Lead Regulatory Document Reviewer

400

Is it true that the LRDR will send a final fax to the CML/MRA and CRA when regulatory document release is reached?

Yes when you receive this fax you have =Regulatory Release for the site

500

Can a CRA make a TIV visit without a fully executed contract?

No

Site Feasibility

100

What group presents to the CML/MRA packets with potential MD information on a rolling basis?

CSI/ Site Feasibility

200

A PI calls you and says that they are running two trials for BI and have already signed a CDA for both of those trials. He ask why must I sign another one for my third trial? How do you respond?

You must sign a CDA for every trial they are trial specific

300

You receive a call from a CSI rep and they ask if they can send out the SFQ. What must you check before you say they can?

Have to make sure there is a signed CDA in house

400

You are at your desk and are on a conference call with the CML/CRA Manager/CRA & you have finalized your list of PIs. Who will the CML send the final listing to for approval?

Director of CTMA

500

What does IIQ stand for?

IIQ=Initial Interest Questionnaire

1572

100

Your at work and receive a call from Sabrina/site coordinator who ask you what she needs to do if the PI is changing at her site. What direction do you give her? What will you do to capture that you gave instruction to this site coordinator?

Advise Sabrina to complete the 1572 and send the wet signature to the CML via mail and to keep a copy in the ISF. Also you would capture this conversation on a Site Contact form sign and date & send to CML to sign and date.

200

You are on a phone call with a new CSI rep and you are telling them that it is okay to send the SFQ because you have a CDA in house. You hear the rep say they are going to just pop it in the mail. What would you tell the CSI rep regarding how to send the SFQ

It has trial specific info and must go via secure mail.

300

Your on the job today and your CML ask you to send the IB to a brand new site. What are you going to put at the subject line first when you are sending proprietary information?

400

You have just completed the 1572 change form and have now uploaded the 1572 form and the change form into the TMF. What is your next step?

Email RA group at service mailbox to advise of 1572

500

You are asked to send a Subject Enrollment Log to a site. Would you encrypt this email? How do you encrypt?

Yes,