Clinical trial management part 11 compliance
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Clinical Trial Management & Part 11 Compliance. Ginger Clasby, MS Exec. VP, Business Development [email protected] Background What is Good Clinical Practice?. A process enabling reliable decisions about allowing a medical product to be marketed. Product Approval Factors .

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Clinical Trial Management & Part 11 Compliance

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Clinical trial management part 11 compliance

Clinical Trial Management & Part 11 Compliance

Ginger Clasby, MS

Exec. VP, Business Development

[email protected]

Background what is good clinical practice

BackgroundWhat is Good Clinical Practice?

A process enabling reliable decisions about

allowing a medical product to be marketed

Product approval factors

Product Approval Factors

  • Product is safe

  • Treatment is effective for disease or condition it is meant to treat

Clinical research project principles

Clinical Research Project Principles

  • Control bias in subject selection

  • Compensate for placebo effect

  • Reduce examiner bias

  • Objectively compare results to other treatments or controls

  • Produce sufficient statistical power

The study protocol

The Study Protocol

  • Explains problem & proposes treatment hypothesis

  • Describes key variables to assess safety & efficacy

  • Specifies & justifies study sample size

  • Describes study population

The study protocol1

The Study Protocol

  • Identifies exams and allowable measurement intervals

  • Specifies clinical and data endpoints

  • Explains how data collected will be analyzed

Study team

Study Team

Study SiteSponsor/CRO

Protocol implementation

Protocol Implementation

  • Qualified study sites

  • Appropriate equipment & instrumentation

  • Adequate training of study team

  • Appropriate data collection instruments

  • Adequate data storage mechanism

  • Adequate study monitoring

Monitoring study progress

Monitoring Study Progress

  • Subject enrollment

  • Subject accountability at study exams

  • Data recorded & collected

Standard study data documents

Standard Study Data Documents

  • Source documents

  • Data capture forms (CRFs)

  • Data query forms

Source document

Source Document

Initial capture of clinical history data, impressions,

diagnoses and plans of care

  • Hospital records

  • Clinic/office charts

  • Lab reports

  • Subject Diaries

Source document1

Source Document

Required to substantiate data submitted to

sponsor via CRFs

Data capture forms

Data Capture Forms

  • Case Report Form (CRF)

  • Electronic Data Capture (e-CRF)

Case report form completion

Case Report Form Completion

  • Formally authorized staff for CRF entries

  • Complete all fields in (black) ink

  • No unnecessary marks or notations

  • Data changes must not obliterate original entry

  • Changes must be initialed and dated

  • Investigator signs CRFs after finalization

Data flow at site

Data Flow at Site

Site sees subject, records exam data on source doc

Site transcribes source data to CRF

Study monitor verifies data capture & submits to sponsor

Data flow at sponsor cro

Data Flow at Sponsor/CRO

Sponsor/CRO enters data to database (#1)

Sponsor/CRO enters data to database (#2) – “verifies”

Sponsor/CROvisually reviews CRF data/logic checks

Data query forms

Data Query Forms

  • After CRFs reviewed by sponsor/CRO, further verification or clarification may be required

  • Provide traceability regarding data changes

Data queries

Data Queries

  • Data queries generated by sponsor/CRO for resolution by site

  • Formally authorized staff for query responses

  • Completed queries must be signed by investigator or authorized staff

  • Copy of completed data queries filed at site

  • Query records in sponsor’s permanent database

Data queries1

Data Queries

Data query flow

Data Query Flow

Sponsor/CROvisually reviews CRF data/logic checks

Sponsor/CROgenerates data query form & sends

Siteresponds to query & returns

Sponsor/CROrevises database entry as necessary

Using computerized systems in clinical trials

Using Computerized Systemsin Clinical Trials

General principles system definitions

General PrinciplesSystem Definitions

  • Protocol should identify when computerized system is used

  • Documentation should identify hardware & software used

General principles source documents

General PrinciplesSource Documents

  • Retain to reconstruct & evaluate trial

  • Investigators retain originals or certified copies

  • When original observations entered directly, e-record is “source”

General principles data accountability

General PrinciplesData Accountability

  • All info for each subject attributable to that subject

  • Record changes shouldn’t obscure original info

  • Record changes should be indicated & means provided to check prior entry

  • Necessity of audit trail – who changed & why?

General principles thoughtful system design

General PrinciplesThoughtful System Design

  • Matches data capture requirements (kg. vs. lb.)

  • Precludes errors in modification, maintenance, archiving, retrieval or transmission

  • Ensures record keeping & retention are in-line with paper systems

General principles security measures

General PrinciplesSecurity Measures

  • To prevent unauthorized access to data

  • To prevent unauthorized access to computerized system

General principles fda records access

General PrinciplesFDA Records Access

May inspect all records intended to support


E data flow at site

e-Data Flow at Site

Site sees subject, records exam data on source doc

Site inputs data to computer & “commits”

E data flow at sponsor cro

e-Data Flow at Sponsor/CRO

Study monitor visually reviews “committed” data vs. “source”

Sponsor/CROreviews CRF data/applies logic checks

Data processing responsibility

Data Processing Responsibility

Additional site qualification questions

Additional Site Qualification Questions

  • Previous experience/comfort level with e-data collection activities?

  • Computer/high-speed internet accessibility?

  • On-site technical support capabilities?

Additional site management planning

Additional Site Management Planning

  • Site & subject training and documentation for e-data capture

  • Ongoing monitor communication & support

  • Technical “Help Desk”

  • E-signature management

Add l systems design issues data entry

Add’l Systems Design IssuesData Entry

  • Prompts for clinical terms & measurements

  • Prompts for out of range data

  • Electronic diaries & e-CRFs designed to allow annotations

  • Features to facilitate data review & identify changes

  • Sponsor access to data during study

Add l systems design issues electronic signatures

Add’l Systems Design IssuesElectronic Signatures

  • Individual enters signature at start of data entry session

  • Attributability of signatures

  • Passwords changed at established intervals

Add l systems design issues date time stamps

Add’l Systems Design Issues Date/Time Stamps

  • Controls to ensure correct system date/time (yr, mo, day, hr, min)

  • Limited ability (with documentation) to change date/time

Add l systems design issues controls

Add’l Systems Design IssuesControls

  • SOPs to maintain system integrity in light of changes

  • Revalidation for changes exceeding operation limits/design specs

  • Documentation of software versions

  • SOPs for contingency plans

Add l systems design issues controls1

Add’l Systems Design IssuesControls

  • SOPs for backup & recovery of e-records

  • Logs to assess nature & scope of data loss in the event of system failure

  • Secure storage of backup records

Consider speed of data capture vs costs incurred

Consider Speed of Data Capture vs. Costs Incurred

Clinical project planning

Clinical Project Planning

  • Skilled, regularly available technical support

  • Detailed hazard/failure analyses

  • Skilled, regularly available monitoring/training support

  • Increased budget for site participation

  • Adequate schedule “padding” for things to go wrong

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