protocol deviations: documenting, managing & reporting · 2015-03-30 · to ec? corrective...
TRANSCRIPT
Samir Dahbane
eClinical Data Manager
Clinical Development Unit – NRC - Lausanne Switzerland
Protocol Deviations:Documenting, Managing & Reporting
13.Nov.2014
Title of the presentation - Name of speaker – CDU function
Competence Pillars to support our ResearchProgrammes in Nestlé
Healthy Ageing
Healthy Pleasure
Sustainable Nutrition
First 1’000 Days & Healthy Kids
Food Safety & Integrity
Nutrition & Health Research
Public Health Nutrition
Food Science & Technology
Food Consumer Interaction
Analytical Sciences
Food Safety & Quality
Clinical Development Unit
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
The Clinical Development Unit (CDU)
p. 3
• Design and execute the clinical development plans that best fit the strategies of the different businesses.
• Conduct many different types of clinical trials in healthy subjects, as well as in patients
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Global Distribution of Clinical Trials
CDU
Global Reach
Staff: 55+
Switzerland, USA,China, Singapore
Clinical Trials: 80+
Fully compliant withinternationalregulations forhuman research
R&D in Nestlé
Innovating the Future in Nutrition, Health and Wellness
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function p. 5
Definition
Samir DAHBANE – eClinical Data Manager
Protocol Deviation: Any divergence from the study protocolthat may affect the data integrity or study process credibility.
May affect the definition of PP/ITT populations.
The Investigator is responsible for reporting ProtocolDeviations to the Sponsor, Ethics Committee, CompetentAuthority…
Title of the presentation - Name of speaker – CDU function
Categorisation
p. 6
ProtocolDeviations
Process Driven:SOP, GCP …
AutomaticTracking
ManualTracking
Data Driven
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Listing
p. 7
Protocol DeviationCategory
Protocol Deviationdescription
ClassWay oftracking
Withdrawalof the
subject ?
Submissionto EC?
CorrectivePreventive
Action
Trial visit schedule notfollowed
Out of visit window V1> V0 + 15 days
Minor Automatic No No
Informed consent processnot adequately performed
Use of wrong versionof informed consent
Major Manual No No
Defined at the study set-up phase
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Listing
p. 8
Protocol DeviationCategory
Protocol Deviationdescription
ClassWay oftracking
Withdrawalof the
subject ?
Submissionto EC?
CAPA
Trial visit schedule notfollowed
Out of visit window V1> V0 + 15 days
Minor Automatic No No
Informed consent process notadequately performed
Use of wrong versionof informed consent
Major Manual No No
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Automatic tracking
p. 9Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Automatic tracking
p. 10Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Automatic tracking
p. 11Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Listing
p. 12
Protocol DeviationCategory
Protocol Deviationdescription
ClassWay oftracking
Withdrawalof the
subject ?
Submissionto EC?
CAPA
Trial visit schedule notfollowed
Out of visit window V1> V0 + 15 days
Minor Automatic No No
Informed consent processnot adequately performed
Use of wrong versionof informed consent
Major Manual No No
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Manual Tracking
p. 13
• Site• Sponsor
• SponsorOnly
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Manual Tracking
p. 14
Protocol Deviation Role
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Manual Tracking
p. 15
• Site• Sponsor
• SponsorOnly
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Manual Tracking
p. 16Samir DAHBANE – eClinical Data Manager
Prot Dev.creation
CustomFunction
GlobalCF
Title of the presentation - Name of speaker – CDU function
Reporting
p. 17
ProtocolDeviations
SDTMDataset
MetricsUpdate
RegularReview
Recurrent PD:Find Root Cause
+ CAPA
ManualAutomatic
Risk BasedMonitoring
Samir DAHBANE – eClinical Data Manager
BOXI
Title of the presentation - Name of speaker – CDU function
Conclusion
p. 18
3 Main Points
Merging
&
SDTM
Regular review & CAPA
Pre-definition of Protocol Deviations
StudyConduct
Close-out
Samir DAHBANE – eClinical Data Manager
Title of the presentation - Name of speaker – CDU function
Questions?
p. 19Samir DAHBANE – eClinical Data Manager