NINR DSM Policy Extramural Clinical Trials 2019
audio/video recordings), protocol adherence, and flow of essential data
forms.
• A description of security measures in place to protect data sources,
protect and back up databases, including how data will be labeled and
stored. (NIH Grants Policy 2.3.12 Protecting Sensitive Data and
Information Used in Research)
• A description of data handling practices that ensure data changes are
documented and there is no deletion of entered data, security systems
prevent unauthorized access to data, adequate backup of data,
blinding is safeguarded. (ICH Harmonized Tripartite Guidelines for
Good Clinical Practice ICH GCP 5.5.3, 21 CFR, Part 11, Subpart B)
• A description of quality assurance measures (and timeline) used to
verify data integrity and validity, including reviewing data collection
forms for completeness and accuracy of the data, verifying
accuracy of data in electronic databases, as well as protocol
compliance. (ICH GCP 5.1)
• A description of how participant data confidentiality will be protected.
The plan should delineate steps that will be taken to monitor and
maintain confidentiality of data (e.g., password protected encrypted
electronic records, limited access) and any limits to confidentiality
(e.g., abuse, suicidal ideation) (§46.111, CFR 21, Part 11, Subpart B,
ICH GCP 2.11, NIH GPS 2.3.12). An additional level of protection for
human subjects involved in clinical studies is a Certificate of
Confidentiality, which is issued to a researcher to provide special
privacy protection to subjects involved in clinical research.
https://grants.nih.gov/policy/humansubjects/coc.htm
d.
Procedures for identifying, reviewing, and reporting adverse events and
unanticipated problems to the IRB, NINR, and FDA (if applicable). If
applicable, the type and number of events that would halt accrual and would
generate a review of eligibility, monitoring, assessments, intervention, and
how the resumption of accrual would occur. For further information, see:
NIH Guidance on Reporting Adverse Events to Institutional Review
Boards for NIH-Supported Multicenter Clinical Trials
(http://grants1.nih.gov/grants/guide/notice-files/not99-107.html)
OHRP Guidance on Reviewing and Reporting Unanticipated Problems
Involving Risks to Subjects or Others and Adverse Events
(http://www.hhs.gov/ohrp/policy/advevntguid.html)
e.
For multi-site studies, procedures to ensure compliance with the monitoring
plan and reporting requirements across study sites.
f.
An assessment of external factors or relevant information (e.g., developments
in the literature, results of related studies) that may have an impact on the
safety of participants or on the ethics for the research study.
g.
The advanced plans for interim and/or futility analysis as appropriate.
If monitoring plan information is found in institutional or consortium or network standard
operating procedures and documents, then the DSM plan does not need to repeat the
information. However, the DSM plan should have a brief summary of the essential elements
as outlined above with a reference to the applicable standard operating procedures.