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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

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 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

submissions


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



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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