CRC Training Study Guide DAY 2

CAPA

A fancy phrase for work you are likely already doing.

Auditing

An independent, systematic review of a clinical trial to assess compliance with federal regulations, sponsor requirements, and institutional policies Snapshot overview of the trial conduct

2 years after

An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of _____ _____ ________ the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.

2 years

An investigator shall retain records required to be maintained under this part for a period of _______ ________following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.

What is the Emory Electronic Medical Record project?

The transformation of patient care through technology and process redesign across all Emory Healthcare entities

Why do I need to be credentialed?

To provide a culture of safety To protect the Emory good name To follow The Joint Commission standards To define the scope of role authorized To standardize and verify levels of competency for skills To abide by legal standards

FDA

allows an investigator to delegate responsibilities

What is a clinical trial

as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). C are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

Emory faculty member

assumes the role and all responsibilities of a sponsor in addition to those of an investigator

Safe subjects + quality data =?

happy Institution

ClinCard

is a web based, reloadable, prepaid card that automates disbursements for study participants

The Trust Line

is operated by an independent third party who will maintain the caller's anonymity, while ensuring that the caller's report is routed to the proper individuals within the University

Investigator

is responsible for ensuring that an investigation is conducted according to the investigational plan and applicable regulations

The investigator

is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.

Documentation

is the key to demonstrating that the protocol & regulations have been followed. should provide assurance that the rights, safety, and well being of subjects are protected, and that the clinical trial data are credible

What is a termination report?

serves as notification to the Emory IRB that continuing review of the study is no longer needed.

Sponsors

should provide guidance to investigators and/or the investigators' designated representatives on making error corrections.

The investigator

should retain records of the changes and corrections.

Drug Inspection Readiness

•Document delivery/return of drug •Document pill diaries •All prescriptions must be signed by authorized prescriber •Print name, phone number and date under signature

Benefits of ClinCard

•Preferred payment method. Safer and faster alternative to cash, A/P checks, and gift cards •Direct, on-site disbursement •Increased participation retention •Reduces payment administration •Improved funds workflow security/approval •Enhanced tracking and reporting

sponsor

•Records should be sent to the ___________ unless the _____________ in writing specifies that the records can be destroyed.

Device Inspection Readiness

•Responsible for all recordkeeping •Maintain a device accountability log

National Gift Card (NGC)

•Submit e-gift card request through the punch-out supplier ____________ _______ ________

Inspection may be:

'for cause' or 'not for cause'

The Following must be completed when closing out a study:

- Protocol indicated research activities including interaction with subjects and collection of data or specimens. - Collection of data about subjects even when no subject contact is necessary. - "Cleaning" of data. - analysis of identified or linked data for research purposes or during the publication process. - any other research use of the data which involves access to identified or linked (coded) data or specimens collected during the conduct of research. -Sponsor close-out visit is completed and all outstanding issues have been addressed. -All contractual and budgetary issues are completed. -Institutional databases reflect subject's data appropriately (i.e. ERMS, EeMR).

Methods for Paying Study Participants

-ClinCard -E-Gift cards -Check -Direct Deposit

CAPA

1.Decrease organizational and personal risks caused by noncompliance during clinical investigations. 2.Decrease response time to noncompliance - secure compliance. 3.Provide consistency in the handling of noncompliance. 4.Document with transparency that our actions or the lack of are defendable.

CAPA Procedures

1.Identification - clearly define the problem 2.Evaluation - appraise the magnitude and impact 3.Investigation - make a plan to research the problem 4.Analysis - perform a thorough assessment 5.Action Plan - create a list of required tasks 6.Implementation - execute the action plan 7.Follow Up - verify and assess the effectiveness

the Research Integrity Officer (RIO)

Call __________ ___________ ___________ ___________ to discuss the matter confidentially and obtain guidance

What does CAPA stand for?

Corrective and Preventive Action

Regulatory files contain study specific what?

Documents

What is EeMR?

Emory Electronic Medical Record

Who needs to be authorized?

Everyone except Medial Staff

Office of Compliance IRB CTAC

For-cause or Directed

Good Clinical Practice (GCP)

ICH-E6 provides standards which delineate documentation required to demonstrate compliance with regulatory requirements. provides lists of Essential Documents for the Conduct of a Clinical Trial

What should not be kept in a regulatory file?

Internal audit/quality management reports Financial information Subject information

Who needs to be privileged?

Medical Staff

Clinical Trials Audit and Compliance (CTAC)

Not-for-cause

Monitoring

Ongoing process of overseeing the progress of a clinical trial and to assess compliance with all of the above Review of trial conduct from start to finish

Regulatory Files

Provide the ability to recreate the study from start to finish Organize study information, communications, & documentation May or may not be a physical binder.

Subject Files

Regulations refer to as case histories Provide the ability to recreate the subject's participation Include documentation that the rights, safety, and well being of subjects are protected Include information recorded on case report forms (CRFs) and source records

25 years

Retain consent forms for minors for __________ _________after the submission of the final expenditure report.

source data

Supporting data or "________ _______" is contained in "source documents"

Preventive Actions

The process for detecting a potential problem and eliminating it

Corrective Actions

The process of reacting to an existing problem and fixing it.

Termination report

When a study ends, is closed, canceled for any reason, or is prematurely completed you must complete a ___________ _______ with Emory IRB

What is CPOE?

computerized provider order entry consist of Medical & Nursing plans of care. Research nurses and coordinators (mandatory training required)

What are SOPs (Standard Operating Procedures)?

detailed, written instructions to achieve uniformity of the performance of a specific function Assure that the right things are done consistently, by the right people, in the right way. Provide documentation of processes. Ensure data integrity (reliability and validity) and completeness.

Fabrication

making up of Research data or results and recording or reporting them

Falsification

manipulating Research materials, equipment, or processes, or changing or omitting data or results such that the Research is not accurately represented in the Research Records

Subject Files contain what?

subject specific documents

GCP

tells you how to document the delegated tasks

Plagiarism

the appropriation of another person's ideas, processes, results or words without giving appropriate credit

Fees Associated with ClinCard

•Cost of card - $2.85 per card •Cost to load card each time you put money on it - $1.15 per card •Replacement card if the patient calls ClinCard helpdesk to get one - $15.00 •Replacement card if the study provides from their stockpile- $2.85