Welcome to Seattle Cancer Care Alliance | Seattle Cancer ...



Purpose of This Form:

THE PURPOSE OF THIS FORM IS TO FACILITATE THE IMPLEMENTATION OF RESEARCH PROTOCOLS THAT WILL UTILIZE THE SEATTLE CANCER CARE ALLIANCE AS A PERFORMANCE SITE. PRINCIPAL INVESTIGATORS OR THEIR DESIGNEE WILL COMPLETE THIS FORM TO PROVIDE SPECIFIC INFORMATION ABOUT THE PROTOCOL AND RELATED ACTIVITIES. SCCA RIO, OPERATIONAL MANAGERS OR THEIR DESIGNEE, IMPLEMENTATION REVIEW COMMITTEE MEMBERS, CLINICAL RESEARCH BILLING AND THE COMPLIANCE REPRESENTATIVES WILL REVIEW THE SUBMITTED FORM AND IDENTIFY ANY ISSUES THAT MAY NEED TO BE ADDRESSED PRIOR TO THE STUDY OPENING. THIS REVIEW MAY BE PERFORMED AT AN IMPLEMENTATION MEETING WITH THE STUDY STAFF AND APPROPRIATE SCCA OPERATIONAL AREAS OR THE REVIEW COULD BE CONDUCTED VIA EMAIL. THIS REVIEW WILL NOT INVOLVE SCIENTIFIC MERIT OF CLINICAL TRIALS OR DUPLICATE THE IRB PROCESS.

POLICY:

COMPLETION AND SUBMISSION OF THIS FORM IS REQUIRED FOR ANY RESEARCH PROTOCOL WITH ACTIVITIES OCCURRING AT THE SEATTLE CANCER CARE ALLIANCE.

INSTRUCTIONS:

1. FILL IN THE HEADER: CLICK ON “VIEW”, CLICK ON “HEADER AND FOOTER” AND COMPLETE ALL FIELDS. THIS INFORMATION WILL NOW APPEAR ON ALL SUBSEQUENT PAGES. TO RETURN TO THE MAIN BODY OF THE DOCUMENT, CLICK ON “VIEW” AND “HEADER FOOTER” (SEE BELOW FOR INFORMATION ON SUBMISSION TYPE);

2. COMPLETE THE OVERVIEW PAGE;

3. COMPLETE THE APPROPRIATE SECTION FOR EACH RESEARCH RELATED SERVICE/ITEM NEEDED DEPENDING ON WHERE IN THE SERVICE/ITEM WILL BE PERFORMED/DELIVERED AND FOR EACH PERFORMANCE SITE, FILL IN AS MUCH INFORMATION AS POSSIBLE;

4. ATTACH THE COMPLETED FORM TO YOUR SUBMISSION WITHIN THE STUDY REVIEW AND MANAGEMENT PORTAL (SRAMP):

i.

5. THE RIO WILL TRIAGE YOUR SUBMISSION AND RESPOND WITHIN 2 BUSINESS DAYS TO CONFIRM AN IMPLEMENTATION REVIEW NEEDS AND/OR REQUEST ANY MISSING INFORMATION.

SUBMISSION CATEGORIES:

NEW (IMPLEMENTATION REVIEW): FOR ALL NEW PROTOCOLS; DETERMINATION OF IMPLEMENTATION REVIEW REQUIREMENTS ARE MADE DURING TRIAGE.

PROTOCOL AMENDMENT: APPLICABLE FOR PROTOCOL AMENDMENTS FOLLOWING INITIAL SUBMISSION THROUGHOUT THE LIFECYCLE OF THE PROTOCOL; WOULD NOT APPLY FOR ADMINISTRATIVE AMENDMENTS.

MODIFICATION/UPDATE: APPLICABLE FOR ANY CHANGE TO CONTENT OF AN ORIGINAL SUBMISSION (E.G. CHANGE IN SERVICE AREAS, SERVICES REQUIRED AND/OR PERFORMANCE SITES).

QUESTIONS:

➢ IF YOU HAVE ANY QUESTIONS REGARDING THIS FORM OR THE IMPLEMENTATION REVIEW PROCESS, PLEASE CONTACT RIO@ OR CALL 288-7116.

➢ IF YOU HAVE QUESTIONS ABOUT COMPLETING A POWERPLAN BUILD TEMPLATE, PLEASE CONTACT DORSEE ZABALLERO AT DORSEE@ OR CALL 288-1350.

➢ IF YOU REQUIRE ACCESS TO SRAMP, PLEASE CONTACT THE SCCA USER ACCESS ADMINISTRATOR AT UAA@ TO CONFIRM YOUR SCCA NETWORK ACCESS AND TO REQUEST SRAMP ACCESS.

OVERVIEW

PLEASE COMPLETE THE TABLE BELOW TO IDENTIFY PERFORMANCE SITES FOR PROTOCOL RELATED ACTIVITIES AND DETERMINE WHICH SECTIONS OF THE FORM ARE APPLICABLE FOR YOUR PROTOCOL. GO TO THE APPLICABLE SECTIONS AND PROVIDE REQUIRED INFORMATION. THE DETAILS YOU INCLUDE ON THIS FORM WILL AID THE IMPLEMENTATION STAKEHOLDERS IN REVIEWING THE RESEARCH PROTOCOL AND RECONCILING CONTENT CONTAINED IN THE BILLING GRID AND SCCA PRICING REQUEST TABLE.

IF THERE ARE CHANGES TO ANY OF THE ANSWERS BELOW AFTER INITIAL SUBMISSION AT ANY TIME-POINT THROUGHOUT THE LIFECYCLE OF A RESEARCH PROTOCOL, YOU MUST SUBMIT AN UPDATED RIO SUBMISSION WITHIN SRAMP.

|PERFORMANCE SITES |BILLING CATEGORY |APPLICABLE SECTION(S) |

|SCCA (SOUTH LAKE UNION) | NO |

|IF YOU ANSWERED “MAYBE” ABOVE, PLEASE EXPLAIN WHY. |      |

|IN ADDITION TO THE SITES ABOVE, WILL THIS STUDY BE AVAILABLE THROUGH THE SCCA NETWORK? |NO YES IF YES, WHO HAVE YOU BEEN WORKING WITH:       |

|IF INPATIENT ACTIVITY IS NOT PLANNED, WHAT COULD CAUSE PATIENTS TO BE ADMITTED WHILE ON PROTOCOL? |      |

|WOULD PATIENTS REMAIN ON PROTOCOL IF ADMITTED? |NO YES |

|WILL PATIENTS REQUIRE ISOLATION DURING ANY OF THEIR VISITS? | NO YES IF YES, WHY:       |

|IS THIS A “DEEMED QUALIFIED” STUDY? | NO YES |

|WILL THE COST OF DRUG ADMINISTRATION BILL TO INSURANCE PER THE MEDICARE NCD? |NO YES N/A |

|IS THIS CONSIDERED AN “IMMUNOTHERAPY STUDY” (I.E., CAR T-CELL, WT-1, VACCINE, ANTIBODY CONJUGATE, ETC.)? | NO YES IF YES, IDENTIFY TYPE:       |

|WILL NON-SCCA EQUIPMENT BE BROUGHT INTO THE CLINIC AND USED FOR PATIENT CARE BECAUSE OF THIS STUDY? | NO YES IF YES, IDENTIFY TYPE:       |

|WILL ALL STUDY PARTICIPANTS BE REGISTERED SCCA PATIENTS? | NO YES |

|WILL PREPRINTED PAPER ORDERS (PPO) BE CREATED? | NO MAYBE YES IF YES, REFER TO SECTION E. |

|WILL PROTOCOL SPECIFIC POWERPLANS (PP) BE CREATED? |NO MAYBE YES IF YES, REFER TO SECTION E. |

|WILL SCCA EMPLOYED STAFF BE LISTED ON THE STUDY’S DELEGATION OF AUTHORITY (DOA) FORM?  | NO YES IF YES, PLEASE NOTE WHICH STAFF AND WHY:       |

|IS THE PI REQUESTING TO REDUCE OR WAIVE FEES FOR RESEARCH? |NO YES |

|WHO WILL BE THE RESEARCH COORDINATOR AFTER THE STUDY OPENS? |      |

|IS THIS PROTOCOL SIMILAR OR THE SAME AS ANOTHER STUDY OPENED AT THE SCCA? IF YES, INCLUDE PROTOCOL NUMBER(S): |      |

|BMT STUDIES: PLEASE PROVIDE INFORMATION RELATED TO THE TYPE OF TRANSPLANT INCLUDED IN YOUR STUDY. | AUTOLOGOUS ALLOGENEIC/RELATED ALLOGENEIC/UNRELATED |

|IF THE PROTOCOL INVOLVES UNRELATED DONORS, DO THE DONORS NEED TO SIGN SEPARATE CONSENT TO PARTICIPATE IN THE RESEARCH? |PBSC BM CORD BLOOD |

| |NO YES |

|OTHER ITEMS/ISSUES TO NOTE FOR CONSIDERATION (E.G. WOULD |      |

|LIKE PATIENTS TO BE SEEN IN THE CLINICAL TRIALS UNIT | |

|(CTU): | |

SECTION A

| |OVERVIEW OF SCCA (SOUTH LAKE UNION) SERVICES |

| |PLEASE INDICATE WITH AN “X” WHICH AREAS WILL BE IMPACTED BY PROTOCOL RELATED SERVICES WHICH ARE BILL TO THIRD PARTY/PATIENT (RS) AND BILL TO RESEARCH (R). |

| |PLEASE COMPLETE THE APPLICABLE SECTION BELOW FOR ALL SCCA SERVICE AREAS MARKED WITH AN X. |

| |ALLIANCE LAB |CLINIC – 3RD FLOOR |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|CLINIC (3RD, 4TH) |WILL INVESTIGATIONAL DRUG BE ADMINISTERED IN CLINIC? NO YES |WILL THE 3RD FLOOR TREATMENT ROOM BE USED? NO YES IF YES, INDICATE FOR WHAT ACTIVITIES:       |

| |IF YES ANSWER THE FOLLOWING: |WILL THE PI/PROVIDER PERFORM REQUIRED RESEARCH ACTIVITIES? NO YES |

| |HOW WILL INVESTIGATIONAL DRUG BE ADMINISTERED? PO SC/IM OTHER |WILL MEDICATIONS BE PULLED FROM PYXIS FOR PROCEDURES? NO YES |

| |WHO WILL ADMINISTER DRUG? PI PROVIDER RN PT (SELF-ADMINISTER) | |

| |HOW WILL PATIENT OBTAIN DRUG?       |IS CLINIC STAFF ASSISTANCE FOR PROTOCOL RELATED ACTIVITIES (E.G. ECG, NASAL SWABS) REQUIRED? NO YES |

| |ARE THERE DOCUMENTATION REQUIREMENTS FOR ORAL DRUG ADMINISTRATION PER PROTOCOL? NO YES |IF YES, DESCRIBE NEEDS:       |

| | |WILL THE STUDY TEAM BE PRESENT AND RESPONSIBLE FOR ANY STUDY RELATED ACTIVITIES IN CLINIC? NO YES IF|

| | |YES, WHAT ACTIVITIES:       |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|CLINIC (BMT) |WILL INVESTIGATIONAL DRUG BE ADMINISTERED IN CLINIC? NO YES |IS CLINIC STAFF ASSISTANCE FOR PROTOCOL RELATED ACTIVITIES (E.G. ECG, NASAL SWABS) REQUIRED? NO YES |

| |HOW WILL INVESTIGATIONAL DRUG BE ADMINISTERED? PO SC/IM OTHER |IF YES, DESCRIBE NEEDS:       |

| |WHO WILL ADMINISTER DRUG? PI PROVIDER RN PT (SELF-ADMINISTER) | |

| |WILL PATIENTS BRING STUDY MEDICATION TO BE ADMINISTERED IN THE CLINIC? |WILL THE STUDY TEAM BE PRESENT AND RESPONSIBLE FOR ANY STUDY RELATED ACTIVITIES IN CLINIC? NO YES IF|

| |NO YES, IF SO: HOW WILL PATIENT OBTAIN DRUG?       |YES, WHAT ACTIVITIES:       |

| | | |

| |DOES THE PROTOCOL REQUIRE PROCEDURES IN THE BMT CLINIC? NO YES | |

| |IF YES, TYPE:       WHO WILL PERFORM:       | |

| |WILL MEDICATIONS BE PULLED FROM PYXIS FOR PROCEDURES? NO YES | |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|CLINIC (IMTX) |WILL INVESTIGATIONAL DRUG BE ADMINISTERED IN CLINIC? NO YES |DOES THE PROTOCOL HAVE OBSERVATION, MONITORING AND/OR SAMPLE COLLECTION REQUIREMENTS: NO YES IF YES,|

| |WHO WILL ADMINISTER DRUG? PI PROVIDER RN PT (SELF-ADMINISTER) |DESCRIBE THE PROTOCOL NEED BELOW: |

| |WILL PATIENTS BRING STUDY MEDICATION TO BE ADMINISTERED IN THE CLINIC? |OBSERVATION REQUIREMENTS:       |

| |NO YES, IF SO: HOW WILL PATIENT OBTAIN DRUG?       |MONITORING REQUIREMENTS:       |

| | |RESEARCH BLOOD COLLECTION REQUIREMENTS: PK PG OTHER:       |

| |DOES THE PROTOCOL REQUIRE INVASIVE PROCEDURES WHICH WILL BE PERFORMED IN THE IMTX CLINIC? |TIME POINTS FOR COLLECTION:       |

| |NO YES |IV LINE PLACEMENT REQUIRED FOR SAMPLE COLLECTION: NO YES |

| |IF YES, TYPE:       WHO WILL PERFORM:       |PROCESSING LAB LOCATION: IMTX RESEARCH LAB OTHER:       |

| |WILL MEDICATIONS BE PULLED FROM PYXIS FOR PROCEDURES? NO YES |SCCA SPECIALTY LAB TESTING: NO YES IF YES, WHICH:       |

| |WILL THE STUDY TEAM BE PRESENT AND RESPONSIBLE FOR ANY STUDY RELATED ACTIVITIES IN CLINIC? | |

| |NO YES IF YES, WHAT ACTIVITIES:       | |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|INFUSION SERVICES |WILL NON-IV DRUG BE ADMINISTERED IN INFUSION OR CTU? NO YES |DOES THE PROTOCOL HAVE ANY OBSERVATION, MONITORING AND/OR SAMPLE COLLECTION REQUIREMENTS: NO YES IF |

|& CTU |WILL PATIENTS BRING STUDY MEDICATION FROM HOME TO BE ADMINISTERED IN INFUSION SERVICES? NO |YES, DESCRIBE THE PROTOCOL NEEDS BELOW: |

| |YES |OBSERVATION REQUIREMENTS:       |

| |IS THE STUDY REQUESTING THAT PATIENTS BE SCHEDULED IN THE CTU? NO YES |MONITORING REQUIREMENTS:       |

| |WILL CELL BASED PRODUCTS BE ADMINISTERED IN INFUSION SERVICES? NO YES |RESEARCH BLOOD SAMPLE COLLECTION REQUIREMENTS: |

| |IS ASSISTANCE REQUIRED FOR PROTOCOL RELATED ACTIVITIES (E.G. ECGS, PULSE OXIMETRY): NO YES|PK PG OTHER:       |

| |SPECIFY:       |TIME POINTS FOR COLLECTION:       |

| | |IS IV LINE PLACEMENT NEEDED FOR SAMPLE COLLECTION? NO YES |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|INVESTIGATIONAL |INVESTIGATIONAL DRUG NAME(S):       |HOW WILL PATIENTS TAKE PO DRUG? N/A SELF-ADMINISTER (DURING APPT.) SELF-ADMINISTER (AT HOME) OTHER:|

|DRUG SERVICES |ROUTE OF ADMINISTRATION: IV PO OTHER:       |      |

|(IDS) |DRUG CATEGORY/CLASSIFICATION (IF KNOWN):       |IS DRUG BEING SHIPPED OFF-SITE? NO YES |

| |ARE THERE OTHER DRUGS COVERED BY SPONSOR? NO YES |IS SCCA IDS A COORDINATING CENTER (FOR A MULTICENTER TRIAL)? NO YES |

| |IF YES, WHAT DRUG(S): |WILL SEDATION OR GENERAL ANESTHESIA QUOTES BE REQUIRED FOR RESEARCH BILLABLE PROCEDURES? NO YES |

| |COMING FROM: SPONSOR COMMERCIAL SUPPLY | |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|IMAGING & NUCLEAR |WHAT IS THE RADIATION SAFETY (HSRAC) APPROVAL STATUS? APPROVED PENDING N/A |

|MEDICINE |ARE RESEARCH TUMOR ASSESSMENTS (E.G., RECIST, CHESON) REQUIRED PER PROTOCOL? NO YES |

| |DOES THE PROTOCOL REQUIRE IMAGING WHICH WILL BE PERFORMED IN A “NON-STANDARD” WAY? NO YES IF YES, DESCRIBE:       |

| |ARE THERE ANY NUCLEAR MEDICINE DISPENSING AND/OR ADMINISTRATION NEEDS? NO YES IF YES, PLEASE DESCRIBE:       |

| |ARE THERE ANY SAMPLE COLLECTION AND/OR MONITORING NEEDS? NO YES IF YES, PLEASE DESCRIBE:       |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|PROCEDURE SUITE & |WHAT PROCEDURE(S) WILL BE PERFORMED?       |

|INTERVENTIONAL |WILL THERE BE MINIMAL OR MODERATE SEDATION MEDICATIONS INVOLVED? NO YES |

|RADIOLOGY |WILL GENERAL ANESTHESIA BE NEEDED? NO YES |

| |WILL ADDITIONAL SAMPLES BE TAKEN FOR RESEARCH PURPOSES DURING ROUTINE BIOPSY PROCEDURES? NO YES |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|APHERESIS |WILL ANY PART OF THE COLLECTED PRODUCT BE ADMINISTERED TO A PATIENT? NO YES |

| |WILL THE DONOR/PATIENT RECEIVE A MOBILIZING AGENT (E.G. G-CSF) PRIOR TO COLLECTION? NO YES |

| |VOLUME OF BLOOD TO BE PROCESSED FOR COLLECTION: < 12L 12L (STANDARD) > 12 L |

| |WILL STANDARD ANTICOAGULATION BE USED (ACD-A + HEPARIN)? NO YES |

| |DOES THE PROTOCOL REQUIRE ANY RESEARCH SAMPLE DRAWS FROM EITHER THE PATIENT/DONOR OR COLLECTED PRODUCT PRIOR TO TRANSPORT TO THE PROCESSING LAB? NO YES |

| |LABORATORY THE PRODUCT IS TO BE SENT TO FOR PROCESSING:       |

| |DOES THE PROTOCOL REQUIRE ANY SPECIAL CELL COLLECTION NEEDS THAT WOULD REQUIRE APHERESIS SERVICES BEYOND STANDARD CELL COLLECTION? NO YES |

| |IF YES, PROVIDE DETAILS:       |

| |HAVE YOU BEEN WORKING WITH APHERESIS FOR PROTOCOL NEEDS?: NO YES |

| |IF YES, WHO ARE YOU WORKING WITH?       |

|CELL THERAPY |DOES THE PROTOCOL REQUIRE ANY CELL SELECTION(S) OR OTHER SPECIAL PROCESSING NEEDS THAT WOULD REQUIRE CTL’S SERVICES BEYOND STANDARD CELL PROCESSING, CRYOPRESERVATION OR INFUSION? NO YES IF YES,|

| |PLEASE PROVIDE DETAILS:       |

| |DOES THE PROTOCOL REQUIRE ANY RESEARCH SAMPLE DRAWS FROM THE COLLECTED PRODUCT IN THE CTL? NO YES |

| |IF YES, PROVIDE DETAILS ON HOW THE SAMPLE SHOULD BE COLLECTED AND/OR TRANSFERRED:       |

| |HAVE YOU BEEN WORKING WITH CELL THERAPY FOR PROTOCOL NEEDS?: NO YES |

| |IF YES, WHO ARE YOU WORKING WITH?       |

|OTHER |SPECIFY AREA:       |

| |ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

SECTION B

| |OVERVIEW OF UWMC SERVICES |

| |PLEASE INDICATE WITH AN “X” WHICH AREAS WILL BE IMPACTED BY PROTOCOL RELATED SERVICES WHICH ARE BILL TO THIRD PARTY/PATIENT (RS) AND BILL TO RESEARCH (R). |

| |PLEASE COMPLETE THE APPLICABLE SECTION BELOW FOR ALL UWMC SERVICE AREAS MARKED WITH AN X. |

| |8SE (OP) |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|INPATIENT - |AT WHAT TIME POINTS DO YOU ANTICIPATE PATIENTS TO BE ADMITTED ON THIS STUDY?       |

|8NE, 7NE, 7SE, & 6SA |IS MONITORING [VITAL SIGNS (OR PULSE OXIMETRY), RESEARCH DRAWS] REQUIRED MORE FREQUENTLY THAN STANDARD NURSING POLICY? NO YES |

| |IS THERE OBSERVATIONAL MONITORING AND/OR SAMPLE COLLECTION REQUIREMENTS ABOVE THE UWMC POLICY ALLOWANCE? NO YES |

| |ARE ECGS REQUIRED PER PROTOCOL? NO YES |

| |IS THERE FLEXIBILITY IN TIMING FOR PROTOCOL RELATED ACTIVITIES? NO YES |

| |WHAT IS THE PLAN FOR ENSURING COMPLIANCE IF PROTOCOL REQUIREMENTS ARE NOT FLEXIBLE AND/OR EXCEED STANDARDS?       |

| |IS THERE RESEARCH TESTING ACTIVITY REQUIRED BY UW RESEARCH TESTING SERVICES (RTS)? NO YES |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

| |PLEASE DESCRIBE THE RESEARCH RELATED ACTIVITIES OCCURRING:       |

|CRC (7S) |ARE RESEARCH STAFF PERFORMING ANY PROTOCOL RELATED ACTIVITIES AT CRC? NO YES |

| |COULD ACTIVITIES MOVE TO THE SCCA SLU CLINIC? NO YES |

| |HAVE YOU IDENTIFIED A COMMUNICATION PLAN FOR THE STUDY TEAM AND THE CLINICAL TEAM RELATED TO PATIENT FLOW BETWEEN SITES? NO YES |

|INVESTIGATIONAL DRUG SERVICES |INVESTIGATIONAL DRUG NAME(S):       |WILL SEDATION OR GENERAL ANESTHESIA QUOTES BE REQUIRED FOR RESEARCH BILLABLE PROCEDURES? NO YES |

|(IDS) & PHARMACY |ROUTE OF ADMINISTRATION: IV PO OTHER:       |IS DRUG BEING SHIPPED OFF-SITE? NO YES |

| |DRUG CATEGORY/CLASSIFICATION (IF KNOWN):       |IS UWMC A COORDINATING CENTER (FOR A MULTICENTER TRIAL)? NO YES |

| |OTHER DRUGS COVERED BY SPONSOR:       | |

| |DRUGS COMING FROM: SPONSOR COMMERCIAL SUPPLY | |

SECTION C

| |OVERVIEW OF SCCA AT EVERGREENHEALTH (SCCA EH) SERVICES – COMMUNITY SITE |

| |PLEASE DESCRIBE THE PROTOCOL RELATED SERVICES WHICH ARE BILL TO THIRD PARTY/PATIENT (RS) AND BILL TO RESEARCH (R) – (NOTE: SCCA SERVICES LIMITED TO LAB, INFUSION, IDS & PHARMACY) |

|RS | |

|R | |

PLEASE DESCRIBE ANY OTHER SERVICES PLANNED TO OCCUR AT SCCA EH OR ELSEWHERE ON THE EVERGREENHEALTH CAMPUS:      

HAVE YOU CONTACTED BETH KING (COMMUNITY SITE MANAGER)? NO YES

| |OVERVIEW OF SCCA AT NORTHWEST HOSPITAL (SCCA NWH) SERVICES – COMMUNITY SITE |

| |PLEASE DESCRIBE THE PROTOCOL RELATED SERVICES WHICH ARE BILL TO THIRD PARTY/PATIENT (RS) AND BILL TO RESEARCH (R) – (NOTE: SCCA SERVICES LIMITED TO RADIATION ONCOLOGY) |

|RS |      |

|R |      |

PLEASE DESCRIBE ANY OTHER SERVICES PLANNED TO OCCUR AT SCCA NWH OR ELSEWHERE ON THE NORTHWEST HOSPITAL CAMPUS:      

HAVE YOU CONTACTED BETH KING (COMMUNITY SITE MANAGER)? NO YES

| |OVERVIEW OF OR OTHER SITE SERVICES |

| |PLEASE DESCRIBE THE PROTOCOL RELATED SERVICES WHICH ARE BILL TO THIRD PARTY/PATIENT (RS) AND BILL TO RESEARCH (R). |

|RS |      |

|R |      |

SECTION D

| |OVERVIEW OF SEATTLE CHILDREN’S SERVICES |

| |PLEASE INDICATE WITH AN “X” WHICH AREAS WILL BE IMPACTED BY PROTOCOL RELATED SERVICES WHICH ARE BILL TO THIRD PARTY/PATIENT (RS) AND BILL TO RESEARCH (R). |

| |PLEASE COMPLETE THE APPLICABLE SECTION BELOW FOR ALL SC SERVICE AREAS MARKED WITH AN X. |

| |AMBULATORY NURSING INFUSION (ANI) - OUTPATIENT |

|INPATIENT - |AT WHAT TIME POINTS DO YOU ANTICIPATE PATIENTS TO BE ADMITTED ON THIS STUDY?       |

|FOREST 7 AND FOREST 8 |IS MONITORING [VITAL SIGNS (OR PULSE OXIMETRY), RESEARCH DRAWS] REQUIRED MORE FREQUENTLY THAN STANDARD NURSING POLICY? NO YES |

| |IS THERE OBSERVATIONAL MONITORING AND/OR SAMPLE COLLECTION REQUIREMENTS? NO YES |

| |IS THERE FLEXIBILITY IN TIMING FOR PROTOCOL RELATED ACTIVITIES? NO YES |

| |ARE ECGS REQUIRED PER PROTOCOL? NO YES |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|PEDIATRIC CLINICAL RESEARCH CENTER|PLEASE DESCRIBE THE RESEARCH RELATED ACTIVITIES OCCURRING:       |

|(PCRC) |HAVE YOU SUBMITTED YOUR PCRC APPLICATION FOR SERVICES? NO YES |

| |NOTE: COMPREHENSIVE AVAILABLE SERVICES LISTED ON PCRC APPLICATION VIA ITHS WEBSITE. |

| |DO YOU NEED OVERNIGHT BEDS FOR RESEARCH ACTIVITIES? NO YES |

| |DO YOU NEED PCRC NURSING TO PROVIDE RESEARCH SERVICES AT THE PATIENT’S BEDSIDE IN THE ANI OR INPATIENT UNITS (SCATTER BED VISIT)? NO YES |

| |ARE RESEARCH STAFF PERFORMING ANY PROTOCOL RELATED ACTIVITIES AT PCRC OCEAN 8? NO YES |

| |DO YOU NEED PCRC NURSES FOR PATIENT MONITORING? NO YES IF YES, DURATION OF MONITORING?       |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|INVESTIGATIONAL DRUG SERVICES |INVESTIGATIONAL DRUG NAME(S):       |IS THE SPONSOR PROVIDING OTHER MEDICATIONS (E.G. PREMEDS)? NO YES |

|(IDS) & PHARMACY | |WILL SEDATION OR GENERAL ANESTHESIA QUOTES BE REQUIRED FOR RESEARCH BILLABLE PROCEDURES? NO YES |

| |ROUTE OF ADMINISTRATION: IV PO OTHER:       | |

| |DISPENSING LOCATION(S): INPATIENT CLINIC ANI OTHER:       | |

| |DRUG CATEGORY/CLASSIFICATION (IF KNOWN):       | |

|APHERESIS & |WHAT APHERESIS SERVICE WILL YOU BE USING? SCCA APHERESIS BLOOD WORKS NORTHWEST |

|CELL THERAPY |WILL ANY PART OF THE COLLECTED PRODUCT BE ADMINISTERED TO A PATIENT? NO YES |

| |WILL THE DONOR/PATIENT RECEIVE A MOBILIZING AGENT (E.G. G-CSF) PRIOR TO COLLECTION? NO YES |

| |VOLUME OF BLOOD TO BE PROCESSED FOR COLLECTION: < 12L 12L (STANDARD) > 12 L |

| |WILL STANDARD ANTICOAGULATION BE USED (ACD-A + HEPARIN)? NO YES |

| |PROTOCOL REQUIRES RESEARCH DRAWS FROM EITHER THE PATIENT/DONOR OR COLLECTED PRODUCT PRIOR TO TRANSPORT TO THE PROCESSING LAB? NO YES |

| |LABORATORY THE PRODUCT IS TO BE SENT TO FOR PROCESSING:       |

| |DOES THE PROTOCOL REQUIRE ANY SPECIAL CELL COLLECTION NEEDS THAT WOULD REQUIRE APHERESIS SERVICES BEYOND STANDARD CELL COLLECTION? NO YES |

| |IF YES, PROVIDE DETAILS:       |

| |DOES THE PROTOCOL REQUIRE ANY CELL SELECTION(S) OR OTHER SPECIAL PROCESSING NEEDS THAT WOULD REQUIRE CTL’S SERVICES BEYOND STANDARD CELL PROCESSING, CRYOPRESERVATION OR INFUSION? |

| |NO YES IF YES, PLEASE PROVIDE DETAILS:       |

| |DOES THE PROTOCOL REQUIRE ANY RESEARCH SAMPLE DRAWS FROM THE COLLECTED PRODUCT IN THE CTL? NO YES |

| |IF YES, PROVIDE DETAILS ON HOW THE SAMPLE SHOULD BE COLLECTED AND/OR TRANSFERRED.       |

|RESEARCH LAB SERVICES |PROCESSING / SHIPMENT OF EXISTING SPECIMENS: NO YES |SPECIMENS TO BE PICKED UP BY STUDY TEAM: NO YES |

| |PROCESSING / SHIPMENT OF PROSPECTIVELY COLLECTED SPECIMENS: NO YES |SPECIMENS TO BE SHIPPED BY RLS: NO YES |

| |SPECIMEN COLLECTION DONE BY: PCRC OTHER:       |SPECIMENS TO BE PLACED ON SHUTTLE: NO YES |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|IMAGING & NUCLEAR MEDICINE |WHAT IS THE RADIATION SAFETY APPROVAL STATUS? APPROVED PENDING N/A |

| |*SEATTLE CHILDREN’S RADIATION SAFETY COMMITTEE, DEPARTMENT OF RADIOLOGY, 5C-1 |

| |DOES THE PROTOCOL REQUIRE IMAGING WHICH WILL BE PERFORMED IN A “NON-STANDARD” WAY? NO YES |

| |IF YES, CONTACT RADIOLOGY CLINICAL RESEARCH IMAGING CORE FOR CONSULTATION. |

| |NOTE: COMPREHENSIVE LIST OF AVAILABLE SERVICES ON APPLICATION VIA WEBSITE: RADIOLOGY CLINICAL RESEARCH IMAGING CORE SERVICES |

| |ARE THERE ANY NUCLEAR MEDICINE DISPENSING AND/OR ADMINISTRATION NEEDS? NO YES IF YES, PLEASE DESCRIBE:       |

| |OTHER ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

|OTHER |SPECIFY AREA:       |

| |ITEMS TO NOTE FOR SERVICE AREA CONSIDERATION:       |

COMPREHENSIVE LIST OF SEATTLE CHILDREN’S CENTER FOR CLINICAL AND TRANSLATIONAL RESEARCH IS LOCATED: (CCTR) CORE SERVICES AND FACILITIES)

PLEASE CONTACT MICHELLE PALMER AT 206-884-5617 OR CRBA@ TO INITIATE THE PRICING PROCESS FOR BILL TO RESEARCH SERVICES.

PLEASE CONTACT LAURA WINTER AT 206-987-4329 OR LAURA.WINTER@ TO INITIATE THE ORDER GENERATION PROCESS.

SECTION E

|PREPRINTED ORDER & POWERPLAN RELATED INFORMATION |

| SOLID TUMOR/HEME: | |

| | |

|WILL YOU CREATE PROTOCOL SPECIFIC PREPRINTED ORDERS? NO YES, TYPE: |WILL YOU USE EXISTING TEMPLATES/FAVORITES IN CPOE TO SUPPORT PROTOCOL RELATED ACTIVITIES? NO YES |

|CHEMOTHERAPY RX RX-ORAL CHEMO OTHER:       | |

| |WILL YOU CREATE PROTOCOL SPECIFIC CPOE POWERPLAN(S)? NO YES |

|IF THERE IS A SIMILAR STUDY THAT ORDERS CAN BE MODELED AFTER PLEASE PROVIDE THE PROTOCOL NUMBER:       |IF YES, FOR WHAT PROTOCOL TIME POINTS?       |

|IMMUNOTHERAPY (IMTX): | |

| | |

|WILL YOU LEVERAGE *STANDARD BMT ORDERS / POWERPLANS? NO YES, TYPE: |WILL YOU CREATE PROTOCOL-SPECIFIC PRE-PRINTED ORDERS? NO YES TYPE: |

|ARRIVAL PRETREATMENT EVALUATION INITIATION OF CONDITIONING CHEMOTHERAPY APHERESIS INFUSION |TREATMENT (IDS DRUG) T-CELL INFUSION CELL COLLECTION/PROCESSING RESEARCH LAB OTHER:       |

|DEPARTURE EVALUATION | |

|*IF YOU HAVE QUESTIONS ABOUT BMT STANDARD PRACTICE GUIDELINES (SPC) OR ORDERS/POWERPLANS, PLEASE CONTACT |WILL PROTOCOL SPECIFIC ORDERS/POWERPLANS BE NEEDED FOR UW INPATIENT? NO YES |

|MOLLY CLAWSON AT 288-1048 OR REFER TO SPC RESOURCES AVAILABLE ON CLINICAL FYI. |IF YES, FOR WHAT ACTIVITIES:       |

| | |

|WILL YOU CREATE PROTOCOL-SPECIFIC POWERPLANS? NO YES TYPE: |IF THERE IS A SIMILAR STUDY THAT POWERPLANS CAN BE MODELED AFTER PLEASE PROVIDE THE PROTOCOL NUMBER:       |

|SCREENING/ENROLLMENT ADDITIONAL PRETREATMENT EVAL TREATMENT APHERESIS | |

|INFUSION POST TRANSPLANT EVAL OTHER:       | |

|BLOOD & MARROW TRANSPLANT (BMT): | |

| | |

|WILL YOU USE *STANDARD BMT ORDERS / POWERPLANS FOR THIS PROTOCOL? NO YES, TYPE: : |WILL YOU CREATE PROTOCOL-SPECIFIC PRE-PRINTED ORDERS? NO YES TYPE: |

|ARRIVAL PRETREATMENT EVALUATION INITIATION OF CONDITIONING CHEMOTHERAPY APHERESIS INFUSION |TREATMENT (IDS DRUG) INFUSION CELL COLLECTION/PROCESSING RESEARCH LAB |

|DEPARTURE EVALUATION OTHER:       |OTHER:       |

|*IF YOU HAVE QUESTIONS ABOUT STANDARD PRACTICE GUIDELINES (SPC) OR ORDERS/POWERPLANS, PLEASE CONTACT MOLLY| |

|CLAWSON AT 288-1048 OR REFER TO SPC RESOURCES AVAILABLE ON CLINICAL FYI. |WILL PROTOCOL SPECIFIC ORDERS/POWERPLANS BE NEEDED FOR UW INPATIENT? NO YES |

| |IF YES, FOR WHAT ACTIVITIES:       |

|WILL YOU CREATE PROTOCOL-SPECIFIC POWERPLANS? NO YES, TYPE: | |

|SCREENING/ENROLLMENT ADDITIONAL PRETREATMENT EVAL TREATMENT APHERESIS |IF THERE IS A SIMILAR STUDY THAT POWERPLANS CAN BE MODELED AFTER PLEASE PROVIDE THE PROTOCOL NUMBER:       |

|INFUSION POST TRANSPLANT EVAL OTHER:       | |

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download