CTRC Lab 1. R (old EC area) Rose Zone Elevator A. 16 beds and 2 chair rooms. Vivian Dorsey RN,BSN, MBA,OCN Nurse Manager

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1 Clinical & Translational Research Center CTRC Overview Vivian Dorsey RN,BSN, MBA,OCN Nurse Manager 1 7/30/2009 New Location R (old EC area) Rose Zone Elevator A 16 beds and 2 chair rooms 2 7/30/2009 CTRC-Purpose Outpatient treatment center dedicated to implementing complex Phase I/II studies Dedicated unit for innovative drug development programs Manage the administration of novel investigational agents and coordination of care, lab, Ekgs 3 7/30/2009 CTRC Lab 1

2 Value of the CTRC Provides the infrastructure for clinical research in a controlled environment Administration of investigational agents by experienced RN staff Phlebotomy services-collection, processing, shipping and tracking, storage and quality monitoring Med Tech Available M-F 7-9 pm, EKG services 4 7/30/2009 CTRC Leadership Team Daniel Karp MD, Med Director Cynthia Stewart, RN, MSN, CAD Vivian Dorsey RN, BSN, MBA,OCN,NM Portia Tse, RN, MS,OCN,ANM Dina Harleaux-Grant, RN, BSN, MCPA Passion Sparrow, PhD Lab Mgr, CTRC Kirk Culotta, Pharm D 5 7/30/2009 CTRC: Utilization Process Budget development for CTRC patient care charges and PK costs with CRF submission Submit Utilization Request via Lotus to CTRC box Review of requested resources by CTRC Review Committee Participate in site initiation meeting Arrange in-service for staff-orders, kits, lab sheet 6 7/30/2009 CTRC Lab 2

3 CTRC Hours of Operation Nursing: M and F 7am-11pm T,W, Th 7am-2:30am Lab: M-F 24 hr availability, after 11pm simple time points only Sat/Sun 7am-3:30pm: simple treatments only, no course 1 day 1 complex treatments Closed all institutional holidays 7 7/30/2009 CTRC Contact Numbers Nursing: Tel: Fax: PK Lab: Tel: Fax: Patients must be scheduled to both areas. Notify us of changes, delays, and cancellations Communication is the key! 8 7/30/2009 Scheduling Fax requests to nursing and lab at the same time to schedule pts Limited number of long studies we can accommodate on a daily basis-limited space, staff, want to ensure safe delivery of protocol Course 1, day 1 treatments must be started by 2 pm, M-F patient safety issue-staffed to manage ADR, research staff available to respond to emergencies 9 7/30/2009 CTRC Lab 3

4 Scheduling Lab scheduler is available M-F 7-3:30. Requests submitted after 3:30, will be managed the next business day. Please follow up to ensure your patient was scheduled correctly. We have over 1500 visits per month and receive over 100 faxes a day. 10 7/30/2009 Scheduling Submit cancellation request to lab and nursing, if pt is off study or admitted Call for same day scheduling-must be approved by nursing and lab managers (need to assure adequate staffing, kits, resources) Kits are kept off site in CPB 11 7/30/2009 FYI Patients must arrive chemo ready- we need to have complete orders, IV, labs assessment PAC-New or never accessed at MDACC, they have to be evaluated by infusion therapy and have an X-Ray on file before we can use the port infusion therapy 12 7/30/2009 CTRC Lab 4

5 FYI Send patients to Infusion Therapy for IV placement prior to coming to CTRC If your patient will be treated after 5pm M-F and on the W/E, provide correct contact information for issues or patient concerns. 13 7/30/2009 FYI Home clinics are responsible for scheduling all labs If there are any specific requirements for the protocol, it must be written on the orders 14 7/30/2009 FYI After 1 st patient treated, you need to review our data and contact us if there are any deviations (real time review, not months later) All patients have to be scheduled, we do not accept drop ins A schedule is essential to our managing our increasing volume Notify us if the patient is delayed past their appointment time 15 7/30/2009 CTRC Lab 5

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7 Z-Code Marsha Hofweber Office of Research Education and Regulatory Management Z-Code Objectives Define Z-Code Be able to state situation for appropriate use of Z-Code State process for requesting Z-Code Describe collection process for Z-Code specimen What Is A Z-Code? A system for the purpose of requesting the Diagnostic Centers and the Inpatient Units to collect protocol specific blood specimens. 1

8 In Which Situations May Z-Codes Be Used? Only MDA standard collection tubes Timed specimens do not qualify (pharmacokinetics) Allows coordination of drawing research and routine labs simultaneously How Is A Z-Code Requested? Make request a minimum of 3 weeks prior to protocol initiation Form located in Bulletin of Information Protocol number required Cost Center number required Dedicated pager for life of protocol required 2

9 Check Research Protocol 3

10 Blood Collection for Research Purposes Make Note A different Z-Code will be necessary if blood tests are not identical for each visit. What is the Process for Collecting Z- Coded Blood? Research labs are ordered on form called Outpatient Physician Orders Research Protocol Diagnostic Tests 4

11 Research Protocol Diagnostic Tests Clinic Station and select patient Click on Orders Select Research Protocol Research Protocol Diagnostic Tests (will always be at the top of the list of orders) Form will be populated with patient information What is the Process for Collecting Z- Coded Blood? Lab will print protocol specific instructions with patient specific tube labels Processing area staff pages protocol pager for collection Specimens held up to 48 hours 5

12 Summing Up.. No special tubes may be used Pick up blood specimens within 48 hours Proactive- Check processing area if protocol patient scheduled for blood draw even if page for blood pick up not received Pager number unchanged for life of protocol Plan ahead 6

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14 CLINICAL RESEARCH TRAINING INVESTIGATIONAL PHARMACY SERVICES Investigational Pharmacy Services Sapna Amin, PharmD, BCOP, Kimberly McConnell, PharmD What is an Investigational Drug? Investigational Drug: Any drug that has not yet been approved for commercial use and has not been cleared for sale in interstate commerce by the FDA. This can include any drug that has not yet been approved for the labeled indication by the FDA. (Safety Standards for Medication Use Section 2:10.01) If the study is being conducted under an IND, by definition it is considered an investigational agent regardless of commercial availability Investigational Pharmacy Service >200 Investigational Agents >900 Active Protocols at MDACC Many Protocols also include investigational use of commercially available agents Different dosing, regimens or indications 1

15 Investigational Pharmacy Service Leadership Team Manager: Sapna Amin, PharmD, BCOP Charge Pharmacist: Kim McConnell, PharmD Staff Pharmacists: Madhu Bharatula, MS, RPh Abel Montalvo, MS, RPh Jason Reed, RPh Location and office hours for IPS Location: Main Building, Room B Telephone: (713) Facsimile: (713) Office Hours: Mon-Fri: 8am 5:00pm Saturday: 8am 4:30pm Sunday: 12noon 4:00pm After hours coverage is provided by Technicians and On-Call Service Pharmacists Clinical Services Participation in Protocol Review and Discussion at IRB and CRC Provide support and drug information for all Drug Treatment Protocols Conducted at MD Anderson Cancer Center Review and Assistance in the Development of Physician Order Sets 2

16 Operational Services Pharmaceutical Management of all Investigational Protocols that include drug therapy at MD Anderson Cancer Center Protocol Initiation Procurement and Storage Accountability of Doses Dispensed Resolution of Discrepancies Monitor Visits and Audits Protocol Close Out Randomization and Blinding of Doses Inventory Procurement & Maintenance Ship To Address: MD Anderson Cancer Center Investigational Pharmacy Services 1515 Holcombe Blvd, B Houston, Texas Protocol Activation Office of Protocol Research (OPR) must verify drug arrival for protocol activation. A request for Protocol Activation must be submitted by the Study Team to OPR OPR will contact Investigational Pharmacy to verify that inventory has been received Some exceptions do exist (Example: NCI Protocols that require Patient enrollment prior to Inventory Shipment) 3

17 Dispensing Study Drug A Prescription or Order is required for Study Drug to be dispensed The Patient MUST be entered into PDMS/CORe for dispensing i to occur An accession number will be assigned to the Patient via CORe; Please include this number on the Prescription or Order Pharmacy Staff will verify this information prior to dispensing Investigational Pharmacy Record Keeping Source Documentation Includes: Dose Dispensing and Inventory Movement Sponsor Contact Information Shipment Receipt Sponsor Correspondence Pharmacy Preparation Information Sponsor Visit Tracking All Other Information Pertinent to Pharmacy 4

18 Requesting Data Data coordinators can request dispensing record by filling out Investigational Drug services data request form which can be obtained on line at The requests should include Protocol Number Patient Information Range of dates needed Requestor s Contact Information Reason for Request Monitoring/Auditing visits In order to reserve adequate time for each visit Two to Four weeks advance notification is required for an appointment We will do our best to accommodate all requests Schedule via telephone (x22848) or (invdrugs@mdanderson.org) 5

19 Orders: Required Elements Patient name and medical record number Date and time the order is written Protocol Number Statement whether this is a new order or a change in an existing order If applicable, all elements used to calculate the dose of a chemotherapy agent should be included on the order (height, weight, and/or BSA) Location of Administration Inpatient or Outpatient Orders Orders: Required Elements Indication that written informed consent was obtained Allergies Chemotherapy agent name, dose, route and date of administration for each drug Cycle number and/or week number as appropriate to the regimen Attending physician signature and a second signature (from another licensed health care provider) indicating a double check of dose calculation Prescriptions: Required Elements Patient name and medical record number If applicable, all elements used to calculate the dose of a chemotherapy agent should be included (height, weight, and/or BSA) Protocol Number Drug Name, Dose, Formulation, Instructions for Use Quantity Please do not use Month Supply No Refills are permitted on Investigational Prescriptions Other Pertinent Information If Chemotherapy is prescribed, please use the Chemotherapy Prescription Template Kit Number, if applicable 6

20 Mid Level Practioners The Following may NOT be ordered by Mid Level Practitioners: Controlled substances, Schedules 1 and 2 Chemotherapeutic agents Investigational drugs Radiation Therapy and radiopharmaceuticals Commercially available, agents used as supportive care part of the protocol (Not included as part of IND)- can be prescribed by Mid-Level Practitioners. This does not include Controlled Substances. Delegated Prescriptive Authority Policy: Medical Staff Policy VII.A Drug Returns Drug returns from patients should be returned to research nurses for accountability Patient Drug Returns may be stored for Sponsor review or destroyed by IPS Final accountability and destruction or return must be done within three months of receipt by IPS. All returns will be destroyed three months after drop off date. Patient Returns Accountability Record Template 7

21 Compassionate Investigational New Drug (CIND) Protocols Similar to regular protocols, we will handle the inventory procurement, record keeping, preparation, p and dispensing for CIND protocols CIND Protocols must be submitted and approved via PDOL Each Patient MUST be registered in CORe Special Issues Institutionally approved pumps and administration sets Institutional Policies and Procedures Destruction Policy Temperature Monitoring Resources Clinical Portal ( 8

22 Access to Prescription On Line (POL) Clinical Portal POL Provides the Physicians and their designated agents a quick, effective system for generating and tracking prescriptions Clinical Calculators Body Surface Area Body Mass Index Creatinine Clearance Micromedex Drug and Disease State Information Drug Interactions Patient Information Clinical Pharmacology Pharmacy and Formulary Record Request Form: Investigational Pharmacy Webite 9

23 Micromedex Clinical Pharmacology Pharmacy and Formulary 10

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25 2/3/2009 Clinical Research Audit Program More Information Sylvie Marcy, BSN MHA Manager, Office of Research Education & Regulatory Management

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27 Putting it all Together Leni A. Mathews Joyce E. Brown Office of Research Education and Regulatory Management Objectives Understand Life of a Protocol Identify Resources Exposure to key research items Learn a few tips to succeed in initiating and conducting clinical trials How do I get a Clinical Trial started? 1. Preparation 2. Resources 3. Organization 4. Coordination 5. Collaboration 6. Communication 7. Implementation 8. Evaluation 1

28 Protocol Life cycle Forecast Calendar Screening Baseline Enrollment Registration Randomization Active Monitoring Long Term Follow-up From NCI Website Protocol Preparation 1. Understand Protocol 2. Understand Disease Process 3. Understand Treatments and Drugs 4. Visualize your goal Protocol Resources Ask yourself Who do I need help from to conduct a particular study? Write down the names of departments or persons on a list. Here s an example: Radiation Oncology Lab medicine CTRC/ ATC Neuro Clinic Staff Diagnostic Imaging Neuro Research Staff Practice Outcomes Investigational Pharmacy Business Office 2

29 Organization Protocol Resources/ Organization What do I need to Organize myself for this protocol? Regulatory Binder Check List Cheat Sheet Phone List On Study Note Protocol Resources/ Organization What else do I need? Data Entry guide Toxicity Record Patient Diary Patient Education Material- example- Video Dictation Guide Order Sets New Patient Research Charts Follow up Packets 3

30 Protocol Resources/ Organization A few other needs: Ongoing Concomitant Medication List Tumor Measurement Documentation Sample Clinic Service Requisition Sample Orders Diagnostic/ Other testing forms Protocol Response Documentation Protocol Coordination Read the protocol and identify areas where you many need to coordinate protocol specific testing or treatments. Think about time restrictions. Examples You might have a study which requires patients to receive radiation treatment within one hour of taking a drug. You may need to obtain lab work within three hours of the drug. Think about how to coordinate all of these procedures. Protocol Collaboration Most protocols require effective collaboration. Example: Patients on drug x need a complete neurological evaluation. How do you get the Physician to complete a neurological exam at each visit per protocol? 4

31 Protocol Communication/ Implementation Communication is so important in running clinical trials Example: What if your patient is late for a treatment which is to be administered at 6am in the Infusion Center? The patient called you. Now who do you need to call? What if the patient has a full schedule of events which should fall in sequential order? Multiple Protocol Management How do I manage this protocol along with many others effectively? Organization Pocket Eligibility Cards Binder with all up to date protocols and informed consents. At least have one copy of the latest informed consent for each study- just incase. Multiple Protocol Management How do I manage many protocols and stay organized? Colored Research Charts Contact List for each protocol Detailed Instruction sheet for protocol enrollment and follow up. 5

32 Computer Review Be aware of your passwords and know how to use all the programs which you will need. Here are some of the many programs we use at MD Anderson: MD Anderson Intranet Site CORE PDMS Lotus Notes Tiles UT MDACC directory PDOL ORA MDACC IND Sponsored Studies NCI Sponsored Studies Clinic Station Departmental Folders, Spreadsheets, Excel, Access, File Maker Pro, etc. Sponsor Websites Assistance What can I do to make it easier and learn more? Attend Brown Bag Sessions Request Training Know your way around this huge place Check out Education Center on Inside MD Anderson websitehttp://inside.mdanderson.org/education/edcen ter/index.html Tips Computer- Be aware of where and how to find forms Remember your passwords Always have paper copies in case of computer outages 6

33 Short Cuts Save frequently used websites to your favorites Create short cuts to your desktop Save frequently used forms and templates Tips-Things on your desk/pocket Date Forecaster Desk Calendar ANC calculator BSA calculator online Pocket Calculator Staging Information Contact List Data Entry Keep up to date Tips 7

34 SAE Forms Tips Protocol Deviations/ Violations 4info OPR Who do I contact? Office of Research Education and Regulatory Management IRB Organization Eligibility Cards- Create Pocket Eligibility cards in various colors ID BOB COG123 PCR134 CNS23 8

35 Use Different Colored Folde 9

36 Conclusion Prepare prior to protocol initiation Adjust processes throughout protocol life Ask for help Know your resources Actually Putting it all Together Lisa Dassler Leni Mathews Activity Instructions Clear your desks of everything except a pen. Split into groups of 2. You will have one spiral notebook for your team to write on. There are various stations. You will have two minutes at each station. Each station is labeled with a number. Write down the number of the station and relevant information next to it. Move to the next station when time is called. 10

37 Putting it All Together Activity There are 10 Stations. Each station has an activity to complete. Please write down your answers for each station. Station 1 Station 2 Station 3 Station 4 Station 5

38 Station 6 Station 7 Station 8 Station 9 Station 10