clinical research sop usage survey
TRANSCRIPT
Clinical Research Standard
Operating Procedure (SOP) Usage
Survey Report
Ying Lu, MB, PhD; Denise Owensby, BS, CCRP;
Debary Bell, BS; Michael Wong, MD; Richard Perez, MD
UC Davis Medical Center
July 2011
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Elements of Clinical Trial Quality
2
3
It is a set of written instructions that document a routine or
repetitive activity followed by an organization
The term “SOP” may not always be appropriate
Terms such as protocols, instructions, worksheets, and laboratory
operating procedures may also be used
It is used in healthcare, clinical research, manufacturing, business, and
etc
International Conference on Harmonisation (ICH) defines
SOPs as: "Detailed, written instructions to achieve uniformity of the performance
of a specific function.” (ICH-GCP1.55)
Standard Operating Procedures (SOPs)
Good Clinical Practice (GCP)
4
GCP is an international ethical and scientific quality
standard for designing, conducting, recording, and reporting
trials that involve the participation of human subjects.
GCP provides public assurance for
the rights, safety and well-being of human subjects
involved in research are protected
the rights, safety, and wellbeing
of trial subjects are protected, consistent with the
principles that have their origin in the Declaration of
Helsinki,
the clinical trial data are credible
Clinical Trial Quality Management
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QA & QC -- Quality Assurance & Quality Control "Systems with written SOPs to ensure that trials are conducted and data
are generated, documented (recorded), and reported in compliance with
the protocol, GCP, and the applicable regulatory requirement(s)." (ICH-
GCP 5.1.1)
6 6
GCP Requirements "The sponsor is responsible for implementing and maintaining quality
assurance and quality control systems with written SOPs." (ICH-
GCP 5.1.1)
FDA Warning Letters Relates to SOPs Missing SOPs
Failure to follow established procedures
No evidence that SOPs were followed
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"… you have not submitted the revised SOPs …."
e.g., FDA Warning Letters
UC Davis Clinical Research Studies List
at clinicaltrial.gov
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Key words search:
"University of California, Davis" (Aug. 2011)
248 total clinical trials
57.3% are sponsored by industry, NIH, NCI & other
Federal Agencies
42.7% are sponsored by UC Davis investigators
(investigator-sponsor)
UC Davis Clinical Research Studies List
at clinicaltrial.gov
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UC Davis sponsor (106) & Other sponsors (142)
There are 197 trials are conducted at CA
UC Davis Sponsored Clinical Studies
at clinicaltrial.gov
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UC Davis Sponsor = 106
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40
38 Observational
Drug (I-IV)
Other intervention
Study Objectives
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The purpose of this pilot survey study was to assess
clinical research SOP usage status, provide baseline
information, and identify need for developing an
effective SOP implementation support program.
.
Study Methods
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Subjects: All clinical research personnel who signed up for receiving
email updates on clinical trial information and training announcement
at UC Davis Clinical Translational Science Center (CTSC).
Procedures: This study is exempted by the UC Davis IRB for
anonymous online survey via SurevyMonkey.com. Ten questions, with
sub-questions, multiple choice and open-ended answers, was
developed to collect feedback from clinical research personnel,
regarding SOPs being used across the full spectrum of clinical trial
settings for drugs, devices, biologics, diagnostics and observations.
Statistics: descriptive, Fisher's exact test, or student t-test
Data Collection
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Survey Questionnaires
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1. Do you use SOP in your clinical study(s)?
2. Please indicate SOP resource(s) for your study.
3. Do you use UC Davis IRB SOP?
4. Where did you obtain copy(s) of IRB & CTSC SOP?
5. Do you have an internal or external monitoring program regarding SOP
adherence?
6. Do you use different procedure(s) other than SOP?
7. Rate the importance of SOP in supporting compliance with GCP
8. Your professional responsibility
9. Would you like to receive a summary of this survey?
10. Are you interested in receiving future SOP training information?
• Program Managers
• Research Managers
• Nurse Managers
• Research Nurse
• Head of Biostatistics
• Analyst
• Quality Assurance
• Co-PI & CRC
• Graduate Student
n = 92
Return rate = 10.2%
15
PI
33.7%
Co-PI
7.6%
CRC
34.8%
Other
17.4%
Staff
6.5%
Demographics of SOP Survey Participants
SOP Usage by Survey Respondents
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34%
8%
36%
16%
7% 19
5 4 2
4
12
2
29
13
2
PI Co-PI CRC Other Staff
% of respondents
SOP user
Non-SOP user
PI/Co-PI (n=38, 41.3%) CRC/Other (n=54, 58.7%)
SOP Resources & User Group Profiles
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19% 10%
14%
8% 2%
20%
11%
6%
10%
0%
1%
2%
3%
4%
5%
0% 10% 20% 30%
SO
P U
sage b
y P
I/C
o-P
I
SOP Usage by CRC/Other
% of SOP Provided
NIH
Trial Sponsor Other
CRO
CTSC NCI
CCRC Private
Department
*CCRC – CTSC Clinical Research Center.
**CRO – Contract Research Organization.
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5%
5%
4%
3%
3%
1%
15%
14%
14%
15%
14%
9%
New study
Renewal
Modification
AE/SAE
Deviation
Non-compliance
PI/Co-PI CRC/Other
IRB SOP Resources & User Group Profiles
19
11
36
27
18
PI/co-PI CRC/Other
Mo
nit
ori
ng U
sed
yes
no
SOP Monitoring
Other Working Instructions
20
12 12
9
18 14
25
PI/Co-PI CRC/Other
Nu
mb
er
of
Use
r MOP
Work Instruction
No
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Respondents
(n=92)
PI/Co-PI
(n=38)
CRC/Other
(n=54) P-value
SOP is very
important 11% (4/38) 61% (33/54)
<0.0001
SOP is not
applicable 37% (14/38) 15% (8/54)
Interested in
SOP training 41% (15/37) 68% (36/53) 0.0169
Importance of SOP & Interest in SOP Training
Summary
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Survey Respondents
(n=92)
PI/Co-PI
(n=38, 41%)
CRC/Other
(n=54, 59%)
SOP user 37% (14/38) 82% (44/54)
SOP very important 11% (4/38) 61% (33/54)
SOP not applicable 37% (14/38) 15% (8/54)
SOP monitoring 29% (11/38) 67% (36/54)
SOP training 41% (15/37) 68% (36/53)
IRB SOP usage 21% 79%
Conclusion
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This is an initial effort to assess SOP usage at our institute. This results
might be biased because subjects who do not know GCP or SOP might
chose not to respond.
1. It provided a current usage of SOPs at our institute
2. SOPs were not used by all study respondents including PI, Co-PI, CRC
and other research support staff
3. Considerably fewer PIs and Co-PIs used and were correlated SOPs with
GCP compliance
4. Further studies are necessary to determine whether there is a need to
develop a training program at our institute for supporting investigator–
sponsors and other clinical research professionals in developing and
implementing SOPs in all types of clinical research studies involving
human subjects.
Limitations
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The overall survey response rate was only 10.2%, and
sample size is small for both groups. Target audiences who
do not know GCP or SOP might chose not to respond.
CRCs and study managers more likely have had GCP
training experiences through different resources, such as
UC Davis CTSC annual clinical research training program
and brown bag seminars. Therefore, differences between
these study groups might be biased.
Future Directions
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Plan To further assess SOP usage
To identify need for training
Do To present survey results
To deliver an SOP introductory seminar
Study
To conduct an SOP survey & analyze results
To identify a small group for testing an SOP implementation supporting program
Act To test an SOP support program & monitor changes
Future Direction & Study Timeline
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Plan Do Study Act
10/11 01/12 07/12 12/12
This study cycle
The upcoming cycle
Reference
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•Hector Vizoso PC. A Primer on Good Clinical Practice and Continuous
Quality Improvement in Clinical Research Monitor. 2009(Oct):23-8.
•Theobald K, Capan M, Herbold M, Schinzel S, Hundt F. Quality assurance
in non-interventional studies. Ger Med Sci. 2009;7:Doc29.
•Krockenberger K, Luntz SP, Knaup P. Usage and usability of standard
operating procedures (SOPs) among the coordination centers for
clinical trials (KKS). Methods Inf Med. 2008;47(6):505-10.
•Heeringa S, West BT, Berglund PA. Applied survey data analysis. Boca
Raton, FL: Chapman & Hall/CRC; 2010.
•Nelson EC, Batalden PB, Godfrey MM. Quality by design : a clinical
microsystems approach. 1st ed. [Lebanon, NH] San Francisco: Center
for the Evaluative Clinical Sciences at Dartmouth ; Jossey-Bass/Wiley;
2007.
This study is supported by
Department of Surgery,
UC Davis Medical Center
Lu et. Al., 2011
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Special Thanks to Our
Survey Study Participants