pediatric research coordinator lunch and learn … · pediatric research coordinator lunch and...

The Pediatric Research Office at Children’s of Alabama Children’s Harbor, Suite 302 Campus Address: CHB 302, zip 1711

Pediatric Research Coordinator Lunch and Learn Bradley Lecture Center

12:00 p.m. September 5, 2017

Welcome!

Child Health Research Unit updates

- Rhonda Corvalan, Research Nurse Coordinator Clinical Research Support Program (CRSP)

UAB SOPS – what is needed for pediatrics?

- Melissa McBrayer, Pediatric Research Office (PRO)

How to determine feasibility and budgeting for pediatric studies?

- Meredith Fitz-Gerald, Director Clinical Research Support Program (CRSP)

The next Pediatric Research Coordinator Lunch and Learn is December 13, 2017.

Please complete the brief evaluation.

Thank you!

The Pediatric Research Office at Children’s of Alabama Children’s Harbor, Suite 302 Campus Address: CHB 302, zip 1711

Lunch and Learn handouts are posted on the Department of Pediatrics website. Go to Research, Training Resources, Research Team Training page:

http://www.uab.edu/medicine/peds/research/training-resources/research-team-training

If you are not a COA employee, you some additional steps to gain access to doors for entry (like to the CHRU) and access to the COA network and software.

Badge For COA security access (photo badge to swipe in and out of secure doorways) complete the form: https://www.jotform.com/coa-hris/security. Questions? Email Officer Derrick Storey: [email protected]

Computer For computer access to COA clinical applications through the Gateway or at a COA computer, you must complete COA computer based training. Sign-up for Children's University training via the COA intranet.

1) Complete the IT Education Children's University Request Form: http://iteducation.chsys.org/chex/ited.html You must sign-up for Children's University training via the COA intranet. Cannot access the COA intranet? Let PRO help! Contact Melissa McBrayer ([email protected])

2) Complete the COA Remote Access form: http://www.uab.edu/medicine/peds/images/PRO/COA_remote_access_form_rev3.pdf If you need help identifying the COA employee to sign/submit your form, please contact PRO.

For more information, read the COA IT handout developed by Vera Holloway, COA Senior Applications Analyst for the May Lunch & Learn: http://www.uab.edu/medicine/peds/images/PRO/COA-IT-handout.pdf

Emails to know when building budgets at COA Tests performed at COA: Pam Barlow ([email protected])

Lab: Ki Naik ([email protected])

Pharmacy: Adrienne Travis ([email protected])

UAB Research Education Series 2017 ‐ 2018 v9.3.17 (may be updated)

Topics Dates Location

Stress Management: how to keep from snorkeling (12 -1) 9/7/2017 PCAMS

Round Table: Brown Bag: How do you create Source Documents? (12 -1) 9/12/2017 WPCC-G

ClinicalTrials.gov: an update (12 -1) 9/21/2017 PCAMS

CCTS Lunch and Learn (CTAO, Oncore, CT.gov, ….) (11:30 - 12:45) 9/26/2017 MCSA

Being a mentor or being a resource…what is the difference? (12 -1) 10/5/2017 PCAMS

Round Table: Brown Bag: what do you need that you are not getting? (12 -1) 10/10/2017 WPCC-G

Research 101: Process To Get Started or How To Start a Study Workshop (Steps to Activation) (11 - 1)

10/19/2017 TBD

Building a Budget (11 -1) 10/24/2017 TBD

Research Orientation Program (8a - 12noon) 10/26/2017 PCAMS

Recruitment Workshop: where do we find the subjects? (12 -1) 11/2/2017 TBD

Round Table: Brown Bag (12 -1) 11/7/2017 WPCC-C

Preparing for an FDA audit: what you should know (12 -1) 11/16/2017 TBD

ACRES [Setting Standards] (12 -1) 12/7/2017 TBD

Round Table: Brown Bag (12 -1) 12/12/2017 WPCC-B

Round Table: Brown Bag (12 -1) 1/9/2018 WPCC-G

Consenting Workshop (2 hours) (11 - 1) 1/18/2018 TBD


Internal Quality Control: measuring, assessing and correcting! (repeat!) (12 -1) 2/1/2018 PCAMS


Business Etiquette: you will get there stronger with the right approach (12 -1) 2/15/2018 PCAMS

Building a Budget (11 - 1) 2/27/2018 TBD

Organizational Tools and Regulatory (12 -1) 3/1/2018 PCAMS


IRB workshop (11 -1) 3/15/2018 TBD


Monitor Visits: how to prepare (12-1) 4/5/2018 PCAMS


Herding cats: being organized and working with people (12 -1) 4/17/2018 PCAMS

Budget Negotiating (12 -1) 5/3/2018 PCAMS


Managing Research Account (12 -1) 5/17/2018 PCAMS


Research Pharmacy (12-1) 6/7/2018 PCAMS

Round Table: Brown Bag (12-1) 6/12/2018 WPCC-B

Oncore Capabilities (12 -1) 6/21/2018 PCAMS

Building a Budget (11 - 1) 6/26/2018 TBD

Contact Carla Hauser for information: [email protected]; 5‐2758

UAB Abbreviated Protocol Feasibility Assessment

Page 1 of 2 Version 07.28.17

Title:

Protocol #:

Principle Investigator:

Sponsor/CRO:

Study Phase: Phase I Phase II Phase III Phase IV Study Article:

Drug Administration: PO SQ IM IV

Population Yes No Comments

1. What is the population age?

2. What is the subject health status? life threatening chronic

healthy

3. What type of treatment population is required?

4. What is the number of patients expected to enroll?

5. Is the number of patients to be enrolled at this site realistic?

6. Do we have access to the patient population?

7. Are the inclusion/exclusion too Restrictive? Seasonal issues? Concerns with inclusion/exclusion?

8. Is this study for Clinical Reasons or Academic?

9. Will patients need to be recruited from outside sources?

10. Will enrollment compete with other studies?

11. Do you expect significant adverse Events (AEs/SAEs)?

Protocol Yes No Comments

1. Is the protocol complex with multiple arms?

2. Is the protocol ethical? 3. Do you foresee the IRB having problems with the protocol?

4. Do you foresee any patient compliance issues?

5. Will coordination with other departments/services be required?

6. What departments/services? Lab, Radiology, Pharmacy, Pathology, CCTS: CRU, CRSP, Bionutrition, Biospecimen etc…

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7. Clinical Billables? 8. Duration of study? 9. Inpatient, outpatient or both? 10. Do the visits seem complex and time consuming?

11. Is the dosing schedule complex? Procedures 7. Yes No Comments

1. Are the procedures/clinical assessments complex? Is there a washout period?

2. What procedures will be performed?

3. Does the study collect PK samples?

4. Does the study require time intensive PK sampling?

5. Is special equipment required for the study?

Staff Yes No Comments

1. Is the workload manageable?

2. Is additional training necessary?

3. What training? Start up, diaries, electronic devices? Investigator meeting?

4. Adequate staff to conduct the study?

5. Will the study require extended work hours, on call time, weekends?

6. Additional specialists/consults needed?

7. Will budget cover expenses?

Time Estimates (How many hours of your time do you estimate for the items below?)

1. Recruitment?

2. Conducting visits (all visits)?

3. Monitor visits?

4. Addressing queries?

5. Entering data? Source docs? EDC?

6. Scheduling visits & procedures? Will it be convenient or will pts miss work and school?

7. Managing adverse events?

8. Comments about time requirements? Experience with Sponsor/CRO?

Recommendation Comments

Pursue protocol

Pursue with conditions (explain below)

Do not pursue (explain below)

Comments: Completed by: __________________________________ Date:_________

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Budget Preparation Considerations:

Things to consider while developing a Budget

Departmental Non-Refundable Fees:

Site Evaluation - $xx Cost recovery for site quality evaluations and follow up by sponsor. Fee would still apply for those activities completed at time of invoicing in the event the sponsor elected not to open the trial. Components included:

Itinerary and meeting preparation for pre site visit. Protocol review by potential Principal Investigator, Department

Leadership, and Research Team. Length of visit by sponsor staff for site quality evaluation (include meetings with

Department faculty, clinic staff, MD and research staff). Time and material costs for appropriate faculty and staff to participate in

teleconferences with sponsor and other university departments related to site evaluations.

Follow-up information requested by sponsor and provided by Department faculty and staff via e-mail and phone.

Departmental evaluation meetings. Miscellaneous required supplies (paper, pens, staples, ink cartridges &

other miscellaneous office supplies). Administrative offset costs for required use of copier, printers, phones, computers

and space by faculty and staff related to this project. Prep time for CDA – Confidentiality agreements. Completing site questionnaires for feasibility.

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Administrative Start-Up Costs - $xx Cost recovery for administrative costs related to starting up the trial. Components included:

Printing and copying of protocol, consents and Institutional Review Board for Human Use (IRB) submission packet.

Preparation time and materials for submission to OSP and IRB -all forms needed ie Letter of Agreement for device trials,1572, regulatory paperwork & prep, institutional IRB and Western IRB forms.

Preparation time and materials for additional documentation required (curriculum vitae’s, medical licenses, trainings etc.) – includes all certificates & training required by staff.

Clerical support (filing and organizing all necessary study documentation). Budget creation – Is this a simple, mid -level or complex protocol? HOW MUCH

TIME AND MONEY WILL THIS TRIAL REQUIRE?? What is your overhead rate 30% or 36% or 48.5%? Check with your OSP Officer Budget evaluation and review by potential Principal Investigator, other

participating faculty and research team. Miscellaneous required supplies (paper, pens, staples, binders, file folders, labels,

highlighters & other miscellaneous office supplies). Time and material costs for appropriate faculty and staff to participate in

teleconferences with sponsor and other university departments – training required by sponsor for electronic diaries, E CRFs, databases, IVRS systems etc.

Administrative offset costs for required use of copier, printers, phones, computers and space by faculty and staff related to this project.

Time for SIV. Budget negotiation by potential Principal Investigator Research Staff. Final budget processing by staff. Time and material costs for appropriate faculty and staff to participate in

necessary trial training ie. Investigator Meeting. Time and material costs for faculty and staff to participate in trial initiation start-

up meeting. Source document development. Study team prep ie mock visits and time to organize. Create order template for CRU/Impact/research team. Create Rx for study drug. Time spent for an Investigator’s Meeting or Online Seminar Create study contact information sheet /short cut study info document. Create /use At Risk Account for study.

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Cancellation Fee - $xx In addition to the Site Evaluation fee, in the event the sponsor elected not to open the trial, a $xx Cancelation Fee would also apply for activities completed at time of invoicing. Includes cost recovery for administrative costs related to preparing for the opening of the trial. Components included:

Printing and copying of protocol, consents and Institutional Review Board for Human Use (IRB) submission packet.

Preparation time and materials for submission to OSP, institutional IRB and Western IRB.

Budget creation time. Budget evaluation and review by potential Principal Investigator, other

participating faculty and the research team. Budget negotiation by potential Principal Investigator. Time and material costs for faculty and staff to participate in trial planning and

preparation meetings. Miscellaneous required supplies (paper, pens, staples, binders, file folders, labels,

highlighters & other miscellaneous office supplies). Time and material costs for appropriate faculty and staff to participate in

teleconferences with sponsor and other university departments. Administrative offset costs for required use of copier, printers, phones, computers

and space by faculty and staff related to this project.

Invoicables or Line Items to be included in the Budget: NOTE: Indirect Costs need to be Included

UAB Research Pharmacy Maintenance Fee - $xx (annual charge) For fees associated with the use of the use of the UAB Research Pharmacy, maintenance, refrigerated storage, dispense etc.

Start- up fee Storage fee Dispensing Fee Drug Destruction Maintenance Fee Time for monitor visits – review of logs etc.

UAB Department of Radiology Non-Refundable Start-Up Fee - $xx For start-up fees associated with the use of Radiology services (CT, X-ray, etc.).

Fee for de-identified Fee for special view or protocol procedure

Any Other Departmental Fees:

Administrative Overhead CRO fees ie. Organization/Dept. Fees May be a %

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UAB IRB Fee - $xx For costs associated with the following: UAB’s Institutional Review Board conducting a pre-review of the protocol for institutional requirements, and storage, maintenance, and updating of the file through the life of the protocol at UAB. UAB’s Office of the Conflict of Interest Review Board conducting a review of the responsible personnel on the project and their associated financial interests to ensure any conflicts that may exist are managed appropriately. These reviews occur as needed throughout the life of the protocol at UAB. The Clinical Billing Review (CBR) unit of the UAB Clinical Trials Administrative Office (CTAO) is responsible for conducting a coverage analysis for all clinical trials per UAB policy. This analysis provides an approved billing plan based on an objective determination of items/services that can and cannot be billed to third party payers using Medicare and local payer coverage rules along with clinical care billing guidelines. The CBR is also responsible for conducting reviews of any subsequent protocol amendments that modify the items/services required by the protocol and modifying the approved billing plan as needed. The approved billing plan is used to facilitate an accurate and compliant clinical trial billing process.

Additional Study Costs:

Invoice Fee $xx invoice fee will be added to all invoicable items to recover cost for Research staff to invoice, track, allocate and pay bills for the study. Additionally, invoices paid by sponsor should reference the invoice and service received by sponsor when providing remittance.

Includes paying patients / travel fees / time to develop an invoice for site reimbursement.

IRB Renewal Fees $xx per renewal. Includes cost recovery for Regulatory Officer’s time and supplies needed to file all required paperwork for annual IRB renewals.

IRB Amendment Fees $xx fee per amendments. Includes cost recovery for Regulatory Officer’s time and supplies needed to file all required paperwork for any IRB amendments.

Includes: change of research, ICF change, source document change/update Change in database – sponsor changing adding more for site to collect Re-consenting

WIRB Fees/Costs

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Western Institutional Review Board for Human Use fees and associated costs are not part of the budget sheet or this appendix. These costs are billed separately to sponsor by IRB. Bi-weekly/ Monthly phone calls

ie. Study updates

Coordinator, Non-nurse and PI additional hourly rate this is for extra time it takes to perform the study……

anything that requires extra time and work-can be invoiced as needed

Data entry fee per visit include time for queries, source/ med history, con meds retrieval from medical record.

Annual Administration Fee $xx annually. Includes cost recovery for general financial administration of the trial (invoicing, accounts receivables tracking, payment of trial costs, effort tracking, etc.).

Just to keep trial open

Pre Screening – time to prescreen patients for a study Can you meet enrollment target?

Screen Failures $xx per screen failure for research nurse coordinator time and supplies. make sure they do not bury language in contract about screen failures ie we will pay for a screen failure once 3 pts are enrolled... Monitor Visits During Study $xx per monitor visit (assumes a one-day visit), plus an additional $xx per each additional ½ day. Includes cost recovery for Clinical Studies Unit time and supplies.

Change in monitor fee / multiple monitors fee Remote monitor fee

Close-OutVisit $xx for study close-out visit. Includes cost recovery for research staff and supplies.

Have you been paid for everything and have you paid all bills – some sponsors with hold a % from each payment – have you received it?

Archive Storage Fees $xx data storage fee. Includes cost recovery for off-site storage of study data and records as required. Also includes Coordinator’s/Data Manager’s time and supplies to maintain, track and organize records. Includes cost recovery for off-site storage retrieval costs as well as Coordinator’s/Data Manager’s time and supplies to maintain, track and organize

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records retrieval requests. Data storage fees listed represent an estimate and not an exact figure. Sponsor will be responsible for rates of inflation imposed by off-site storage facility.

Include Archive retrieval fee Lab Storage and Maintenance Fee

Storage of lab kits Time for re-ordering and checking expiration date Time for keeping logs and making sure equipment is certified

FDA Audit $xx per day in the event of an audit of the study by the U.S. Food and Drug Administration (FDA). Includes cost recovery for PI and research team time and supplies.

Audit Prep fee

Additional/Miscellaneous Fees/Costs Payment for shipping costs, image reproduction (i.e. cd’s, dvd’s, etc.) costs and all other miscellaneous costs required by sponsor will be the responsibility of sponsor either via invoice to sponsor through the Department or paid directly to the vendor by sponsor. Additional fees may apply for unknown costs and the time and supplies required by such activities. Costs may be negotiated between the Department and the sponsor. An indirect cost rate of xx% will apply to all of the above costs if invoiced through Department.

More Budget Negotiation Items: The Department reserves the right to renegotiate this contract, the budget and this appendix should the protocol be amended; unanticipated costs arise or if the trial lasts longer than expected.

SAE Reporting and Follow up IND safety Letters –Time for reviewing and storage If the protocol has a special requirement for additional staff

for blinded/unblinded coordinator Coordinator additional hourly rate addressed above Non-nurse additional hourly rate PI additional hourly rate On call fee / after hours

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Audit prep fee Annual meeting & training Shipping prep cost – IATA training & prep time Clinical trial.gov – entry fee Change in database – sponsor changing adding more for site to collect Re-consenting PI Oversight fee Subject Travel, Hotel and Meal tickets for study visit compliance

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PRO LUNCH AND LEARN SEPTEMBER 5, 2017• UPDATES• BUILDING BUDGETS

NEXT PRO LUNCH AND LEARN:December 13,2017 @ noon

PRO Website Research team training page

http://www.uab.edu/medicine/peds/research/training-resources/research-team-training

Lunch and Learn handouts and “cheat sheet” Child Health Research Unit page

http://www.uab.edu/medicine/peds/research/chru Questions? Melissa McBrayer ([email protected])

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Child Health Research Unit Rhonda Corvalan, Clinical Research Support Program

What you can and can not do …. Scheduling Application is on the CHRU page:

http://www.uab.edu/medicine/peds/research/chru

UAB SOPs Website: https://www.uab.edu/ccts/clinical-translation/tools Clinical/Operating (CL)

Adverse Event and Serious Adverse Event Reporting Eligibility Confirmation Monitor Visits (SAV, IMV, COV) PI Oversight Source Document Development Data Management: CRF Completion and Query Resolution

Regulatory/Management (RM) - includes device studies SOP Development Regulatory Document Management Process (Initial and Continuous Submissions) Sponsor, CRO and Internal Audits Required Training Note to File 1572 Management Site Specific Informed Consent Form Administrative Hold Closing a Study Record Storage FDA Audits Drug Accountability

Fiscal Management (FM) Reviewing the Protocol for Financial Impact COI Reporting Monthly Reporting and Reconciliation

What SOPs are missing

for Pediatrics?

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Building Budgets OVERVIEWThe WHENThe WHOThe WHATThe WHYandThe HOW

UAB CCTS Budget WorkshopsSAVE THE DATES:

October 24, 2017 ( 11AM-1PM)

February 27, 2018 ( 11AM-1PM)

June 26, 2018 ( 11AM-1PM)

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The WHEN Start as soon as you get the Protocol! Part of feasibility: do you have the subjects, do you have

the staff and space and CAN YOU AFFORD TO DO THE STUDY?

Complete a Feasibility Assessment Work on budget in parallel with other start up activities

(ie: IRB and Contract language)

Sample Feasibility Assessment

Handout

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Eric Macomb, PRO Informaticist

Supports data retrieval from data warehouse or clinical programs for feasibility assessments, preliminary data, research protocols, etc. and ensures proper oversight of data requests.Contact via PRO [email protected]

Where do you get pricing at COA? Tests performed at COA: Pam Barlow

[email protected]

Lab: Ki [email protected]

Pharmacy: Adrienne Travis [email protected]

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Departmental FeeThe Department of Pediatrics administrative fee is overseen by the departmental Pediatric Research Office, or PRO. This Office supports all components of clinical trials conducted within the Department. It ensures that study personnel are thoroughly trained, that specimen collection and handling meet all appropriate research standards, that specimen storage capacity is adequate for the needs of the trials conducted here, and that all regulatory requirements are fully followed by the research team. It also ensures sufficient research space and facilities for study personnel, including study monitors, and award administration. By providing these services and facilities in a centralized fashion, the PRO ensures that the data generated in the conduct of a clinical trial fully support regulatory approvals and clearances for the product under investigation.

*If more justification is needed please request a letter from Cheryl Perry, PRO Director ([email protected])

Review of Study Protocol and DesignProtocol Review

DepartmentReview

IRB Review

Develop and Negotiate

BudgetContract

Review andNegotiation

Finalize:Budget

ContractIRB

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The WHO The entire research team

PI Coordinator Regulatory personnel Financial / Office Manager Data entry personnel

CPAP process Know your departmental costs

The WHAT (is in the protocol) Review the methods section of the protocol

Know complexities of procedures Know acuity of subjects Know where subjects will be seen

Review the schedule of events in the protocol Know how often subjects will be seen

*Pay attention to the visits, schema and fine print and super script

TRULY THE DEVIL IS IN THE DETAILS!

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Analyze the Protocol Personnel

PI Study Coordinator Data manager/entry Regulatory staff Biostatistician Administrative effort

Laboratory tests Procedures Study drug/device Pharmacy needs Supplies Data storage Long term document storage

MANPOWERIncrease quotes from CBR/FAP by 5% for each year of the

study

Recruitment plan? Subject care/procedures Care/Procedures CRF completion CRF review and update per queries Data base hosting (REDCap, Sharefile, etc.) Billing Effort Study Initiation Costs Reviewing records Time with Monitor

Analyze the Protocol (con’t)

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Analyze the Protocol (con’t) Regulatory Management

Clinicaltrials.gov IRB and local requirements

Pharmacy Costs Start Up Per Subject Dispensing Maintain Accountability and Storage Ordering drug? Drug destruction

Laboratory What are the specimens processed locally? What specimens are sent off site to central lab? Do you have the resources?

Subject Compensation CRF review and updates per queries

Analyze the Protocol (con’t) SAEs Multiple new versions of protocol Monitor visits Extra PI time Extra Coordinator time Extra Data entry time Screen failures Unscheduled visits Cancellation fee IRB renewals FDA audit

INVOICEABLES: THOSE THINGS THAT MIGHT NOT HAPPEN….BUT

WILL!!

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The WHY You must cover your costs OR know upfront who will! A strong budget with strong justification for costs is easier

to negotiate. Negotiate 3 times Be ready to walk away if you believe your justification

KNOW your limits!

Justification Be prepared to quickly justify your costs

Have common language drafted Consider creating budget guidelines for your research area

that describe Research staff, services, experience, Costs and rationale/justification

Update the language frequently

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The HOW Determine Start up costs

Determine per subject cost

Identify invoiceables

Start Up Costs A great deal of effort is expended prior to an executed

contract and active account Identify and track time spent on start up activities

Utilize a tool for tracking your time Software Allocation report Excel Spreadsheet Notebook/Calendar

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Non-Refundable Administrative Start-up Fee Consider the following in estimation: CDA processing Sponsor feasibility / site qualification Attendance at investigator meeting Internal reviews Initial IRB submission activities Regulatory document management Compilation, submission to sponsor, set-up binders

Budget development / negotiation Initiation / start-up meetings

Budget Challenges Start Up Costs Indirect Costs Justification for costs Standard Cost/Fees Operating costs Tracking expenditures & invoices

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Indirect Costs Know which IDC rate applies to your project prior to

negotiating the budget Read the contract Speak with your contract officer Provide justification of the IDC to the sponsor (OSP website)

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Standard Costs Know what it costs to operate your research area Maintain a list of standard or commonly used research

fees/costs Update the costs frequently

Operating Costs Take the time annually to review the costs of running

your research program Phones, network connections Computers, furniture Supplies Education & Training Salaries

Include these in budgets as line items or invoiced items

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Tracking Sponsors typically pay quarterly or upon data entry

which creates challenges in knowing the true account balance

Find a tool that works for you, don’t trust sponsors will always pay the correct amount Software (Oncore, Quickbooks, etc) Spreadsheets

Reconcile accounts monthly

Payment Schedule(in contract) Negotiate according to the flow of the protocol and

estimated financial needs % per enrolled patient % per completed treatment cycle % per “completed” patient (check definition in the

protocol and/or contract) Amount per CRF/ visit on a monthly or quarterly basis

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Billing Compliance

REMINDER:IF THE SPONSOR IS PAYING FOR A

SERVICE,DON’T BILL THIRD PARTY PAYORS!

Post-Study Budget Evaluation Was there a balance in labor vs. reimbursement? What hidden costs were covered or not covered? Were monitoring visits too labor intensive? Was the payment schedule equitable? Is there room for improvement regarding cost of doing

the trial and the bottom line? If you had to do it over again, could you do it for the

same amount (and not require supplemental resources to cover your costs?)

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What are your challenges?