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

Ginger Clasby, MS

Exec. VP, Business Development

[email protected]

BackgroundWhat is Good Clinical Practice?

A process enabling reliable decisions about

allowing a medical product to be marketed

Product Approval Factors

  • Product is safe

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

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

  • Explains problem & proposes treatment hypothesis

  • Describes key variables to assess safety & efficacy

  • Specifies & justifies study sample size

  • Describes study population

The Study Protocol

  • Identifies exams and allowable measurement intervals

  • Specifies clinical and data endpoints

  • Explains how data collected will be analyzed

Study Team

Study SiteSponsor/CRO

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

  • Subject enrollment

  • Subject accountability at study exams

  • Data recorded & collected

Standard Study Data Documents

  • Source documents

  • Data capture forms (CRFs)

  • Data query forms

Source Document

Initial capture of clinical history data, impressions,

diagnoses and plans of care

  • Hospital records

  • Clinic/office charts

  • Lab reports

  • Subject Diaries

Source Document

Required to substantiate data submitted to

sponsor via CRFs

Data Capture Forms

  • Case Report Form (CRF)

  • Electronic Data Capture (e-CRF)

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

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

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

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

  • Provide traceability regarding data changes

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 Queries

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 Systemsin Clinical Trials

General PrinciplesSystem Definitions

  • Protocol should identify when computerized system is used

  • Documentation should identify hardware & software used

General PrinciplesSource Documents

  • Retain to reconstruct & evaluate trial

  • Investigators retain originals or certified copies

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

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 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 PrinciplesSecurity Measures

  • To prevent unauthorized access to data

  • To prevent unauthorized access to computerized system

General PrinciplesFDA Records Access

May inspect all records intended to support


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

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

Sponsor/CROreviews CRF data/applies logic checks

Data Processing Responsibility

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

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

  • Ongoing monitor communication & support

  • Technical “Help Desk”

  • E-signature management

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 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

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

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

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 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

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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