Regulatory
The study protocol follows what set of internationally recognized ethical and scientific quality requirements?
Good Clinical Practice (GCP)
Where is the Kit ID located?
a) on the bag
b) vacutainer stickers & form stickers
c) aliquot tubes
d) on the bag, aliquot tubes, vacutainer stickers, and form stickers
d) on the bag, aliquot tubes, vacutainer stickers, and form stickers
Team members can be activated/inactivated in the database using what Form?
Form 10
Name the 3 Forms in the Registry
Demographic, encounter, transplantation
Which cohort has no upper age restriction for consent: CF or non-CF?
CF
The correct way to make a change on the CRF is?
a) cross out original response & make correction
b) cross out original response, make correction, initial, and date
c) get a new form and fill it out with the new information
d) write-over original response with new information
b) cross out original response, make correction, initial, and date
How many specimen collections should occur in each visit window?
a) 1 BAL AND 1 blood (excludes for-cause visits)
b) Only 1 blood OR 1 BAL (excludes for-cause visits)
a) 1 BAL AND 1 blood (excludes for-cause visits)
When can most data changes be made by your site?
a) within 2 days
b) within the first 24 hours
c) within 7 days
d) you cannot make changes, must submit inquiry
c) within 7 days
How does one change the patient ID in the Registry?
You cannot. Once a number is assigned, even if a record is created erroneously, then deleted, the number will remain and the next record created will continue in sequential order.
Biorepository Blood Collection Form 200 should be entered for every visit window, regardless of collection status?
True or false
True
A participant is considered enrolled when?
a) When the Informed Consent Form is signed
b) When they are officially listed and have a UNOS PxID/TLTP ID
c) Once the first specimen is collected
d) Once the coordinator enters Form 100 in the database
b) When they are officially listed and have a UNOS PxID/TLTP ID
What do you do if you accidentally redraw specimens from a visit window that already had specimens collected?
a) Dispose specimens
b) Process & ask the BCC/CFF for guidance
c) Process specimen & label as "E" for extra in the database
d) Label specimens for the next window visit
c) Process specimen & label as "E" for extra in the database
Since this is a vulnerable population, every effort should be made to ensure this does not happen
What are 3 reasons to complete a Form 120? (6 reasons total)
When a participant:
1. Transfers care to another transplant center
2. Withdraws consent
3. Receives a unilateral transplant
4. Death
5. Removed from waitlist
6. Participant was consented, but never went on to be listed
When should you enter a participant in the Registry?
When you have consented a patient, you should complete the demographics form for the Registry
Besides completing applicable training and filling out the training log, list 5 other requirements that the following team member would be required to complete and send to the BCC before they can start working on the study : Research coordinator responsible for consenting, entering Biorepository & Patient Registry data, and shipping
Any 5 of the following:
b. Principal Investigator
What specimen types have a "step-down" freezing process?
a) PBMCs & Cryo-BALp
b) PAXgene, PBMCs & Cryo-BALp
c) Only PBMCs
d) Only PAXgene
b) PAXgene, PBMCs & Cryo-BALp
Tip: Make sure your Mr Frosty is filled with isopropyl alcohol to the mark indicated on the container. This is what allows the cells to slowly decrease in temperature
In Form 100, the permanent residential ZIP code recorded should be the participant's zip code when?
a) at the time of birth
b) at the time of transplant
c) if relocated for transplant care, relocation ZIP
d) it doesn't matter what ZIP code used
b) at the time of transplant
What steps need to be completed to have access to the Registry?
Be on the delegation log with Registry data entry role assigned and have completed the Registry training and be on the training log.
What are the guidelines for a site to determine frequency of shipping biospecimens?
1. Ship once you have 4 full boxes (about 325 samples). Try not to exceed having 2 shippers worth of samples stored (about 650 samples)
2. Minimum shipment of every 3 months. No individual specimens should be stored at a site for longer than 3 months
Any IRB-approved Informed Consent Form (ICF) can be used to consent participants regardless of IRB approval date
True or False
False
The most recent IRB-approved ICF should be used. Reasons for an updated ICF include but are not limited to: protocol amendment, continuing review/annual report, IRB amendment/modification
What 4 steps need to be taken before a new team member is certified to process samples?
1. Review MOPs Chapter 30
2. Complete training virtually or in-person by a trained team member
3. Complete 3 processing quizzes and submit to cfr-biorep
4. Receive a 100% grade from cfr-biorep (they will inform you it is ok to begin processing)
Biorepository data can be directly entered into the Biorepository specimen database and the Case Report Forms (CRFs) do not need to be printed and filled out
True or false
False
What do I enter if someone has had > 1 double lung transplant?
Enter the lung transplant as appropriate on the transplant form (i.e. denote which one it is [1st, 2nd, 3rd, etc]). If there is already one transplantation form entered, then add a new form for each subsequent.
PMBCs should be collected at all For Cause visits after 12 months unless? (2 circumstances)
There is established CLAD or a bronchoscopy or PBMC collection has been performed within the last 8 weeks