19 Chapter 2: Good Documentation Practices
• E3: Guideline for Industry Structure and
Content of Clinical StudyReports (July
1996) (http://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM073113.
pdf ).This guideline is helpful in developing
a complete, unambiguous, and organized
clinical report.
• Guidance Document: E6(R2): Good
Clinical Practice: Integrated Addendum
to E6(R1) (March 2018) (https://
www.fda.gov/regulatory-informa-
tion/search-fda-guidance-documents/
e6r2-good-clinical-practice-integrated-ad-
dendum-ich-e6r1). This guideline outlines
member countries’ unified standard (GCP)
for documenting, recording, and reporting
human clinical trials and ensuring data
integrity.
• Guidance Document: Q9: Quality Risk Man-
agement (June 2006) (http://www.fda.
gov/downloads/Drugs/GuidanceCompli-
anceRegulatoryInformation/Guidances/
UCM073511.pdf)
• Capture Source Data (ICH GCP E6 1.52)
• Maintain Adequate Records (21 CFR
812.120 (a))
• Requirements for Data Integrity
o §211.68 (requiring that “backup data
are exact and complete” and “secure
from alteration, inadvertent erasures,
or loss”)
o §212.110(b) (requiring data to be
“stored to prevent deterioration or
loss”)
o §211.100 and §211.160 (requiring cer-
tain activities to be “documented at the
time of performance” and laboratory
controls to be “scientifically sound”)
o §211.180 (requiring records to be
retained as “original records,” “true
copies,” or other “accurate reproduc-
tions of the original records”)
o §211.188, §211.194, and §212.60(g)
(requiring “complete information,”
“complete data derived from all
tests,” “complete record of all data,”
and “complete records of all tests
performed”)
• Electronic Signature and Recordkeeping
Requirements (21 CFR Part 11)
• Design Control Guidance for Medical
Device Manufacturers: Guidance for
Industry (March 1997) (http://www.
fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm070642.pdf )
• Guidance for Industry: Computerized Systems
Used in Clinical Investigations (May 2007)
(https://www.fda.gov/regulatory-infor-
mation/search-fda-guidance-documents/
computerized-systems-used-clinical-inves-
tigations)
• Quality System Information for Certain
Premarket Application Reviews: Guidance for
Industry and FDA Staff (3 February 2003)
(https://www.fda.gov/regulatory-infor-
mation/search-fda-guidance-documents/
quality-system-information-certain-pre-
market-application-reviews)
• Guidance for Industry: Q7A Good
Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients
(August 2001) (http://www.fda.
gov/ICECI/ComplianceManuals/
CompliancePolicyGuidanceManual/
ucm200364.htm)
• Guidance for Industry: Quality Systems
Approach to Pharmaceutical CGMP
Regulations (September 2006) (http://www.
fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/UCM070337.pdf )
• Guidance for Industry: Current Good
Manufacturing Practice for Phase 1
Investigational Drugs (July 2008)
(http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/UCM070273.pdf )
• Guidance for Industry: Q10 Pharmaceutical
Quality System (April 2009) (http://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/UCM073517.pdf )
• Guidance for Industry: Process Validation:
General Principles and Practices (January
2011) (http://www.fda.gov/downloads/