Show:
IND
SAE
RDC/Site Feasibility
IMP
Trial Conduct
100
Is it true that the MRA/CML must verify that the actual date of the TIV is correct in CTMS
Yes this is the MRA/CML responsibility. They should check date on trip report and compare with date in CTMS
100
Are AESI & significant events sent to pharmacovigilance as SAEs?
Yes even though by themselves they maybe non serious events they go in serious timelines
100
Is it true that the CRAs must be checking in RDC to see if the PIs have open discrepancies to ensure PIs respond and approve all RDC pages?
Yes this should be done throughout the trial
100
A brand new site coordinator calls you and she says she is trying to understand this IRT system with DPs. She ask you what is the two step process for delivery of drug? How do you respond to this?
There are two steps to drug delivery with IRT system. The first step is POD (electronic signature) for delivery of box of IMP. The second step is the site opening the contents of the box, reviewing the shipping slip with contents, examining the drug and temperature logger & going into IRT system and identifying the drug is available.
100
What timeframe do the CRAs have to get their trip reports in from their visits to sites?
10 days
200
What is the timeframe the FDA gives sponsors for notifying PIs of SAEs
15 days
200
You are at a cocktail party and your friend mentions to you that their grandmother was on Spiriva ad she had to be hospitalized after she took her first dose last Friday because she developed severe difficulty breathing and had tongue swelling and she was hospitalized for 3 days. What is your responsibility as a BI employee
You must report the SAE to pharmacovigilance as soon as possible.
200
When a trial has interim database locks who is responsible to ensure sites have responded to all of GPV questions regarding SAE and have completed and entered all RDC data?
For interim datbase locks the CML/MRA are responsible for following up with sites to ensures PIs close and follow up on all open SAE request from GPV. Remember the CRAs are not necessarily at the sites during interim locks so this responsibility falls to MRAs/CMLS
200
A brand new PI calls you and says he noticed over the weekend the drug temperature dropped 10 degrees below the range recommended. What would you instruct this PI to do? Assume the study has no storm documents
The PI needs to complete the Product Device Form and fax/email to address on the form and quarantine the drug until CTSU advises whether drug can be utilized or not.
200
How would you describe remote monitoring?
Remote monitoring is calling, emailing, or faxing sites in between POSV to monitor how the site is doing and how the subjects are doing. MRAs are involved in remote monitoring
300
If a site coordinator calls you and asks you to provide them with IND SR where would you get them (service mailbox)
zxrdg MedClinOpSAE process mailbox
300
A PI calls you and says a patient just came in for visit 8 and said she was hospitalized over the weekend with vomiting and is pregnant. What do you do? Include all instructions you would give them and where you would document what you told them
You would tell PI to complete a Pregnancy Monitoring Form side A and sign and fax to GPV in 24 hr. You would tell PI to complete SAE form and fax to GPV in 24hr. You would also tell PI to document in med record and AE portion of eCRF. You would capture all of your instruction on a Site Contact Form because this is an important correspondence in that it demonstrates our monitoring of sites
300
A CSI rep calls you and asks if they can send out the SFQ to Dr. Jones office. What do you need to check is in house before you say they can?
You have to make sure we have a signed CDA confidential disclosure agreement
300
A brand new PI calls you and says yesterday they noticed the drug was exposed to temperatures for a evening that were outside the range the drug can be stored at. This study does have storm documents. How do you direct this PI?
You would have the PI fill out the The Drug Storage Temperature Excursion Report and Assessment Form. Once you are trained by CMLs you would also help them look at storm range for drug and make decision if the temp excursion is significant or non significant.
300
Can a TIV occur if the IMP has not arrived at a site?
No. Drug has to be released before TIV
400
Is it true that the CMLs have to complete a CML Alert form if the CRAs send them a CRA Alert form and they know a site has not received IND SR for a period beyond 15 days
Yes
400
A site coordinator calls you and states she does not understand what the Implied Serious List is. How would you explain it to her?
The implied serious list is a list of events BI as a company has decided must always be considered serious regardless of circumstances of report.
400
After the CML and MRA and CRA manager narrow down their choices of investigators who does the CML send the list to in the US for approval?
The CML will send the list to the executive director of CTM (clinical trial management)
400
In an IRT trial where the DP are destroying drug, how does the TCM receive the COD for the TMF?
The DP sends COD to CTSU who provides to the TCM
400
Can a site have a TIV visit if the investigator has not attended an investigational meeting and does not have a certificate of attending training on the protocol?
No we cannot allow TIV visits to PIs that have not had training the TIV would have to be rescheduled
500
If entering a serial number, the first IND field, & actual TIV dates into CTMS are turn ons for IND SR what is the trigger to stop the reports?
LPO (last patient out) plus 30 Days or LPDD (last patient drug date) plus 30 Days
500
A PI calls you and says GPV keeps sending back their SAE because they listed a benign basal cell cancer as non serious. How would you explain to the PI what the issue is?
Tell BI that any new dx of cancer is always a SAE and must be made that on the SAE form
500
Dr. Green wishes to know why he has to complete another CDA for this fourth trial he is doing for BIPI. How do you respond?
CDAs are trial specific. You have to have one signed for each trial you participate in
500
What is the new name BIPI is using for NIMPs?
Auxillary meds
500
Tina a new CRA calls you from a site and says in a panic, "I do not know what to do I can't remember what to do when the site has a subject there is no consent in the chart for the subject?" How would you direct her? Tell me everything you would do in this situation?
I would capture the conversation on a Site Contact Form and tell Tina to instruct the site to obtain consent now from the subject, notify the IRB, gather any information on how this occurred, and tell the CRA you will notify CML and CRA manager so they can start a CAPA. Sign & date Site Contact form and send to CML for them to sign and date