SOP Updates

Tatiana Kurilo, MPH, CCRC Quality Management and Education

Outline • Training on revised SOPs: SOP 3.5: Reporting Unanticipated Problems/Adverse Events SOP 3.7: Preauthorization of Treatment Effective February 2, 2015! * Updated Winship Adverse Event worksheet *

3.5 Reporting Unanticipated Problems/Adverse Events

• Purpose: To standardize the reporting of

significant events for clinical trials. • Scope: All Winship investigators and staff

involved in the management of subjects who participate in cancer-related clinical research trials.

3.5 Reporting Unanticipated Problems/Adverse Events

Procedure:

• It is the Primary Investigator’s (PI)

responsibility to review and assess all adverse events (AE)

• The PI may delegate AE assessment (grading & attribution) to Licensed study staff that is listed on Form 1572 and assigned this task on DOA log unless specified otherwise in the protocol

3.5 Reporting Unanticipated Problems/Adverse Events Procedure:

• The PI is responsible for understanding the

Sponsor’s reporting requirements • The regulatory specialist will submit

reportable events as required to the sponsor and the IRB

• Emory sponsors and sponsor-investigators (S-Is) must fulfill the additional FDA reporting requirements of sponsors

3.5 Reporting Unanticipated Problems/Adverse Events Procedure:

• For SAEs and Ups, the Investigator, with the

assistance of the CRC/CRN, will complete and sign the Emory University Reportable Event Assessment Form

• The regulatory specialist will review the Emory assessment form to determine IRB reporting requirements

3.5 Reporting Unanticipated Problems/Adverse Events Procedure:

• The CRC/CRN will complete the following:

– Enter all events on Winship Adverse Event worksheet in the subject’s study records (available on Intranet)

– Enter all SAE(s) and UP(s) into Oncore® within the SAE category, in timely matter

– Maintain documentation of event(s) assessment and submission in the subject’s study records

– Ensure inclusion of all UP(s) and SAE(s) on the agenda for discussion at the regularly scheduled Working Group meetings

3.7 Preauthorization of Treatment

• Purpose: To ensure that health insurance preauthorization is completed for subjects receiving commercially supplied medications in clinical trials.

• Scope: All Winship investigators and staff involved in the management of subjects who participate in cancer-related clinical research trials.

3.7 Preauthorization of Treatment

Procedure:

• This procedure refers to orders for all studies

with commercially supplied medication that require health insurance preauthorization including IV or injection chemotherapy or any IV or injection medication, therapy or regimen..

3.7 Preauthorization of Treatment

Procedure:

When a subject has signed consent to participate in a clinical trial and trial eligibility is confirmed, the CRC or CRN will complete an order form for that clinical trial with the following information: 1. Anticipated start date 2. Estimated doses of therapeutic agents supplied

based on subject's current height and weight The words “FOR PRECERT ONLY” will be written on the physician signature line.

3.7 Preauthorization of Treatment

Procedure:

• The CRC/CRN will Fax Precert Only orders directly to AIC Scheduler office at 404-778-5819 at least Five business days prior to the planned treatment date

EHC observed holidays are not counted as business days and orders received after 4PM will be considered the following business day.

Questions..

Multi-Site SOP 10.6 Reporting Unanticipated

Problems/Adverse Events

Effective January 30, 2015!

Nikki Brumbelow, MS, CCRC

10.6 Reporting Unanticipated Problems/Adverse Events PI & SI

• PI: Review and assess all AEs & ensure reported to Emory

within protocol specified timelines: SAE & UPs= 24 hours of awareness

• SI: Review and sign off* on every event & return to Winship regulatory staff to report to IRB/FDA, as applicable

* Emory Reportable Event Assessment Form will be used for Participating Sites to complete and SI to review and sign off

10.6 Reporting Unanticipated Problems/Adverse Events Participating Site Responsibilities:

• Complete applicable reporting form per protocol & submit to Winship regulatory

• Report event to their IRB as applicable • Submit acknowledgments from their IRB to Winship

regulatory • Resolve all event related queries in a timely manner • Maintain copies of each event in subject's chart • Enter AEs on an AE worksheet in subject chart • Enter AEs in Oncore®in a timely manner • Enter SAEs and UPs into Oncore® in the SAE Category

in a timely manner

10.6 Reporting Unanticipated Problems/Adverse Events Winship Regulatory Responsibilities:

• Follow IRB policies and procedures • Follow FDA reporting requirements • Ensure SI signs off on all events prior to

submitting

QUESTIONS?

Mastering Clinical Research

For previous presentations and upcoming schedule, visit:

• https://winshipcancer.emory.edu/education/continuing-education/mastering-clinical-research.html

Post Questions

Question 1: The Principal Investigator provides oversight of all adverse events.

A. True B. False

Question 2: The Principal Investigator may delegate attribution of Adverse

Events to:

A. Lead Working Group Coordinator B. Clinical Research Coordinator who

is assigned to the study C. Clinical Research Nurse that is

listed on Form 1572 ans assigned this task on DOA

Question 3: For commercially supplied study drugs the “Precert Only” order

must be Faxed directly to AIC Scheduler:

A. At least one business day prior to patient’s treatment

B. At least Five business days prior to patient’s treatment date

C. After patient receives his/her first study treatment

Question 4: Multi-Site: The Sponsor-Investigator must sign off on every Reportable Event Assessment Form

filled out by participating sites?

A. True B. False

Question 5: Multi-Site: Which of the following is a task for which the Winship

team is responsible?

A. Resolve all event related queries B. Enter AEs on an and AE worksheet in

subject chart C. Ensure SI signs off on all events prior

to submitting the events to IRB/FDA D. Enter SAEs and Ups in OnCore