investigator site audits and gcp compliance shehnaz v2.0
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Investigator Site Audits and GCP Compliance
• Shehnaz Vakharia• Principal Consultant• Theraverity
Disclaimer
• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
• These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
Background
0
20
40
60
80
100
Audits
Investigator Site
Systems
Investigato
r site
audits
Where do we stand ?
Awareness Vs Documented Training
0
20
40
60
80
100
Awareness
ICH GCP
Schedule Y
CDSCO GCP
Investigato
r sites a
udited
Awareness / Documented Training
0
20
40
60
80
100
Documented Training
ICH GCP
Schedule Y
CDSCO GCP
Investigato
r sites a
udited
Institutional Ethics Committee Vs Independent Ethics Committee
0
10
20
30
40
50
60
70
80
90
100
Hospitals Clinics
Institutional EC
Independent EC
% o
f In
vestigato
r sites
Ethics Committee compliance to Schedule Y requirements
0
10
20
30
40
50
60
70
80
90
100
Chairman Members Quorum CTA
Institutional EC
Investigato
r site
s
Ethics Committee
Compliance to EC requirements
010203040506070
8090
100
Annual
Reports
SAEs SAE Other
Investigator
Investigator
Sponsor / CRO
Investigato
r sites
During Study
SOP & Compliance
0
10
20
30
40
50
60
70
80
90
100
Ethics
Committees
Investigator
Sites
SOPs
SOP compliance
Investigato
r sites
SOP Training
0
10
20
30
40
50
60
70
80
90
100
Ethics Committees Investigator Sites
SOPs
Investigato
r sites
Inherent Issues
Lack of Past Medical Records
Inherent Issues
Documentation Practice & Data Reliability
Documentation Practice
Changes
File Notes
Inadvertently!!!!!!
Insertions
Cancellations
Back-dating
Documentation Issues
The source document and the CRF showed the test was performed on 06-Jul-09
The film of the scan however, showed
that the scan had been performed on
08-Jul-09
The subject had been source verified!!!!!!
Source data supporting the Inclusion Criteria
Documentation Issues
Qualifying ECG in a Cardiology study
Documentation Issues
Report supporting the primary efficacy parameters of the study
Documentation Issues
CRF had recorded the initial lesion measurement
Ethics Committee-Documentation Issues
Version numbers and Version dates
Date of signatures
Different letters issued on same dates
Missing links
Registration System
0
10
20
30
40
50
60
70
80
90
100
Institution Private Clinics
In-patientRegistration
OPD Registration
Routine Follow-up Visits
Clinical TrialFollow-upIn
vesti
gato
r sit
es a
ud
ited
Unique Identifier
0
10
20
30
40
50
60
70
80
90
100
Institution Private Clinics
In-patientRegistration
OPD Registration
Routine Follow-up Visits
Clinical TrialFollow-up
Investi
gato
r sit
es a
ud
ited
Practically impossible to cross check past visits
Temperature Monitoring Documentation
Do we identify the storage location on the Temperature Monitoring Logs ?
Do we identify the monitoring device on the Temperature Monitoring Logs ?
Calibration of Temperature Monitoring Device?
Sample Storage & Documentation
Do we have systems, processes & documentation for collection of clinical laboratory samples?
Do we have systems, processes & documentation for storage of clinical laboratory samples?
Do we have documentation of shipment of clinical laboratory samples?
FacilityIn
vestigato
r sites
01020
3040
5060708090
100
Storage Archival Power Back-
up
Fire
Protection
Institutions
Clinics
Calibration Records
Filed in the Investigator Site File? Yes
Comparable to the instruments? Not always
HOWEVER, ON A POSITIVE NOTE…..
0
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2
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4
5
6
7
8
2005 2006 2007 2008 2009 2010
US FDA Inspection
US FDA Inspections -India
Investi
ga
tor
sit
es
INDIA
US FDA Inspection Results
09 of 17 Investigator Sites had ‘NAI’
No Action Indicated. No objectionable conditions or practices were
found during the inspection.
07 of 17 Investigator Sites had ‘VAI’Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily.
01 of 17 Investigator Sites had ‘VAI2’No response requested.
None of them resulted in ‘OAI’
US FDA Inspection Results
Deficiency codes
04: Inadequate drug accountability
05: Failure to follow investigational plan
06: Inadequate and inaccurate records 0
1
2
3
4
5
6
7
4 5 6
US FDA Inspection
Investi
ga
tor
sit
es
Deficiency Code
If we are able to overcome our documentation deficiencies we can
certainly take clinical research in India to a different level!!
Thank You
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