appendix c pd/pk collection worksheets
appendix d pk sample handling

Please note: *As of Amendment H (2/5/2018) blood for PK analysis will no longer be collected.*  
Pharmacokinetic Blood Sampling and Plasma Sample Preparation Affix completed sample labels lengthways to vacutainer and cryovials. Each blood sample must be processed within 1 hour of draw.  
Collect approximately 5 mL of blood in K3 EDTA vacutainer tubes **at room temperature.**
Invert vacutainer gently 8-10 times. Centrifuge at 1500 x g for 10 minutes **at room temperature**.  
Transfer 0.8 mL of plasma into each of three 2-mL cryovials. To avoid contamination, always use a new transfer pipette for each sample, and do not remove the plasma near the precipitate.  
Transfer plasma samples to -70oC freezer (within 2 hours of collection).
Ship 2 cryovials of plasma (primary samples) on dry ice (shipping instructions below). Ship backup samples on dry ice in a separate shipment.
appendix c pd/pk collection worksheets
pk sample shipping log and

Ship PK plasma samples every 3 months or when requested. Use an electronic manifest for each shipment (see below). Each manifest should indicate the subject ID, time points, and number of samples included in the shipment.  
Place samples grouped by subject in cryobox. Ensure the cryobox is closed and remains so in transit using shipping tape. Place the cryobox in a sealable Biohazard bag with an appropriate amount of absorbent.  
Each shipment should be prepared in accordance with IATA regulations. Samples must be shipped at least 3 days prior to US National Holiday.  
Frozen samples should be shipped via Fed Ex, Monday through Wednesday. No shipments should be made later than Wednesday of any given week. (Samples should arrive by Friday, not on the weekend, because it is closed on weekends.)
For questions regarding sample shipment, contact Lara Graham, 610-296-3152, lgraham@alliancepharmaco.com.  
On the day of shipment, e-mail the completed electronic manifest, the tracking number and other appropriate paperwork to Lara Graham (lgraham@alliancepharmaco.com)
Lara Graham Sample management Alliance Pharma 17 Lee Blvd. Malvern, PA19355 Ph: 610-296-3152 lgraham@alliancepharmaco.com Sample PK Shipment Manifest: Talazoparib (BMN 673) Plasma Samples from Study NCI/CTEP \#9510 To: lgraham@alliancepharmaco.com Sponsor: National Cancer Institute/CTEP **P9510** Date Shipped: No. of items shipped: Shipped by:  
| Item  No   | Pt/Sample ID   | Description   | Day   | Time Point   | Cycle   | Draw Date and  Time   | Unit   | Quantity   | Volume   |
|------------|----------------|---------------|-------|--------------|---------|-----------------------|--------|------------|----------|
| 1          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 2          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 3          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 4          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 5          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 6          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 7          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 8          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 9          | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 10         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 11         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 12         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 13         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 14         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 15         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 16         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 17         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |
| 18         | Plasma PK      | cryovial      |       |              |         |                       |        |            |          |