CCIR
Study Manual
GCP
CTRU
Who's Who
100

What is our protocol CCIR number?

What is.. CCIR 1356

100

How many sites are involved in this project?

What is.. 11

100

What does GCP stand for?

What is.. Good Clinical Practice.

100

What floor is the facility located on?

What is.. the fifth floor

100

Who is the PI/ Sponsor for the HEAD study?

Who is... Brian Gordon and the University of Pittsburgh

200

What radiopharmaceuticals does our project utilize? List all possible names.

What is.. 

Amyloid - Pittsburgh Compound B (PIB)

Tau - Tauvid flortiucipir AV 1451

MK6240 

200

What does NCRAD stand for and where is it located?

What is.. the National Centralized Repository for Alzheimer's Disease and Related Dementias located in Indianapolis, IN.

200

What is the LAR and the order of priority?

What is.. legally authorized representative.

1. Spouse

2. Adult child

3. Parent

4. Brother or sister

5. Relative by blood or marriage

200

What cognitive testing is completed in this facility (partially or fully)?

What is.. UDS3, neuro-psych battery, CDR (clinical dementia rating), MMSE (mini mental status exam).

200

Who is the Authorized User for the HEAD study?

Dr. Cyrus Raji

300

What is the radiopharmaceutical half life for the tracers?

What is.. 

Pittsburgh Compound B - 20 min (2 hrs)

AV 1451 - 2 hrs (12 hrs)

MK6240 - 2 hrs (12 hrs)

300

What is the order of the tubes as they are drawn and what do the colors mean?

What is.. PAXgene, Serum, 10 mL Purple Top EDTA, 6 mL Purple Top EDTA

1. RNA analysis

2. Serum

3. Plasma/ buffy coat

4. Whole blood

300
In the event of any imaging/ vital/ health history issues what entity should be contacted?

Who is... the authorized user.... 

1. Cyrus Raji

2. Tammie Benzinger

3. Manu Goyal

4. Matt Brier

300

What are the parameters for centrifuging samples including tube type?

What is.. 4 degrees Celsius, 2000g for 10 min 

*as long as samples look good

5 10mL purple top EDTA tubes and serum tube

300
Who is the point of contact for reimbursements?

Who is... Jamie Vaugh

400

What does CCIR stand for and located on what floor of Barnes-Jewish?

What is.. the Center for Clinical Imaging Research is located on the 10th floor of BJH.

400

How many participants are approved to be enrolled under this protocol?

What is.. 150 participants.

400

Where are protocol deviations reported(3)?

What is... the UPit Regulatory binder, RDRC, IRB
400

Where are samples stored prior to shipment to NCRAD?

Where is... the CORE lab, on the 6th floor of Wohl.

400

Who is the main study coordinator at University of Pittsburgh?

Who is... Firoza Lussier

500

Who can give the injections of any radiopharmaceuticals?

Who is.. Linda Becker, Nick Dunn, Laura Fohne, Nelly Miyazaki, and Shirin Hatami.

500

What information is uploaded into LONI?

What is.. deidentified CSV files and protocol specific images.

500

What is the range of days to follow up with participants once they've received a tracer?

what is... 5-10 days

500

How many pounds are packaged in the shipping container (protocol specific and reality)?

what is... 45 lbs and 39-40 lbs
500

Who releases PET imaging dedicated slots (3)?

Who is.... Jennifer Morgan (cyclotron), Linda Becker (CCIR), Kelley Jackson (Benzinger group)