appendix d pd sample collection
appendix f ctep multicenter guidelines

If an institution wishes to collaborate with other participating institutions in performing a CTEP sponsored research protocol, then the following guidelines must be followed. Responsibility of the Protocol Chair
- The Protocol Chair will be the single liaison with the CTEP Protocol and Information Office (PIO). The Protocol Chair is responsible for the coordination, development, submission, and approval of the protocol as well as its subsequent amendments. The protocol must not be rewritten or modified by anyone other than the Protocol Chair. There will be only one version of the protocol, and each participating institution will use that document. The Protocol Chair is responsible for assuring that all participating institutions are using the correct version of the protocol.  
- The Protocol Chair is responsible for the overall conduct of the study at all participating institutions and for monitoring its progress. All reporting requirements to CTEP are the responsibility of the Protocol Chair.  
- The Protocol Chair is responsible for the timely review of Adverse Events (AE) to assure safety of the patients.  
- The Protocol Chair will be responsible for the review of and timely submission of data for study analysis.  
Responsibilities of the Coordinating Center
- Each participating institution will have an appropriate assurance on file with the Office for Human Research Protection (OHRP), NIH. The Coordinating Center is responsible for assuring that each participating institution has an OHRP assurance and must maintain copies of IRB approvals from each participating site.  
- Prior to the activation of the protocol at each participating institution, an OHRP Form 310 (documentation of IRB approval) must be submitted to the CTEP PIO.  
- The Coordinating Center is responsible for central patient registration. The Coordinating Center is responsible for assuring that IRB approval has been obtained at each participating site prior to the first patient registration from that site.  
- The Coordinating Center is responsible for the preparation of all submitted data for review by the Protocol Chair.  
- The Coordinating Center will maintain documentation of AE reports. There are two options for AE reporting: (1) participating institutions may report directly to CTEP with a copy to the Coordinating Center, or (2) participating institutions report to the Coordinating Center who in turn report to CTEP. The Coordinating Center will submit AE reports to the Protocol Chair for timely review.  
- Audits may be accomplished in one of two ways: (1) source documents and research records for selected patients are brought from participating sites to the Coordinating Center for audit, or (2) selected patient records may be audited on-site at participating sites. If the NCI chooses to have an audit at the Coordinating Center, then the Coordinating Center is responsible for having all source documents, research records, all IRB approval documents, NCI Drug Accountability Record forms, patient registration lists, response assessments scans, x-rays, etc. available for the audit.  
Inclusion of Multicenter Guidelines in the Protocol
- The protocol must include the following minimum information:
- The title page must include the name and address of each participating institution and the name, telephone number and e-mail address of the responsible investigator at each participating institution.  
- The Coordinating Center must be designated on the title page.  
- Central registration of patients is required. The procedures for registration must be stated in the protocol.  
- Data collection forms should be of a common format. Sample forms should be submitted with the protocol. The frequency and timing of data submission forms to the Coordinating Center should be stated.  
- Describe how AEs will be reported from the participating institutions, either directly to CTEP or through the Coordinating Center.  
- Describe how Safety Reports and Action Letters from CTEP will be distributed to participating institutions.
appendix d pd sample collection
agent ordering

Except in very unusual circumstances, each participating institution will order DCTD-supplied investigational agents directly from CTEP (see Section 8.4). Investigational agents may be ordered by a participating site only after the initial IRB approval for the site has been forwarded by the Coordinating Center to the CTEP PIO.
appendix g procedure for samples
collection of biopsies

Materials for shipping biopsy specimens will not be provided. Core needle biopsies and biopsies from dermatologic and ENT lesions should be collected, placed in pre-chilled cryogenic vials, flash frozen in liquid nitrogen within 2 minutes of collection, and shipped on dry ice. Refer to SOP 340507 (https://dctd.cancer.gov/ResearchResources/biomarkers/docs/par/SOP340507_Biopsy_Frozen.pd f ) for detailed instructions on core needle biopsy collection and handling, including the sample shipping manifest, batch record, and instructions for requesting FedEx labels. Sample handling SOPs are still in development for biopsies collected from dermatologic and ENT lesions; please contact FNLCR PD Central Receiving (NCI_PD_Support@mail.nih.gov, 301-846-1951, or 301846-6747) for additional instructions regarding these tissue types.  
Participating *site* **biopsy samples will shipped via FedEx to:**  
  
Attention: NCI-F/FNLCR 1073 Beasley Street, Fort Detrick Frederick, MD 21701 Phone:
At the NCI only, **biopsy samples will be shipped via courier to:**  
  
Attn: Frederick National Laboratory for Cancer Research Leidos Biomedical Research, Inc. 1050 Boyles Street Frederick, MD 21702  
  
 Phone:
appendix g procedure for samples
isolation of ctcs

Prior to CTC collection, each participating site should e-mail a request for specimen collection and shipping materials from NCI_PD_Support@mail.nih.gov. Allow at least six business days for receipt of the blood shipment containers; a confirmation e-mail with the expected shipping date will be sent. Blood (at least 7.5 mL) will be collected aseptically by venipuncture or from a venous port into one 10 mL CellSave preservative tube; the collected blood samples are stable for up to 48 hours at room temperature (15˚C to 30˚C) prior to processing.  
Participating site **CTC samples will be shipped to:**
Attention: NCI-F/FNLCR 1073 Beasley Street, Fort Detrick Frederick, MD 21701 Phone:
At the NCI only, **CTC samples will be shipped via courier to:**
Attn: PADIS CTC Laboratory Frederick National Laboratory for Cancer Research Leidos Biomedical Research, Inc. 1050 Boyles Street
appendix g procedure for samples
frederick md 21702

Phone: 301.846.4711 E-mail NCIPDSupportPADIS@mail.nih.gov prior to shipping CTC samples with expected arrival date/time and a description of contents. All shipments should include a description of contents on the outside label/shipping slip, and a detailed packing slip should be included with the samples. Because of the 48-hour window of CTC sample stability, CTC samples should be shipped to arrive when specified below:  
| Collection Day                                                                                             | Day/time samples must arrive at PADIS   |
|------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Monday                                                                                                     | Wednesday (early morning)               |
| Tuesday                                                                                                    | Thursday (early morning)                |
| Wednesday                                                                                                  | Friday (early morning)                  |
| Thursday                                                                                                   | Friday (early morning)                  |
| CTC samples may not be collected on Fridays Saturday Monday (early morning) Sunday Tuesday (early morning) |                                         |