Self-Monitoring Tools

Key elements that should be reviewed through a peer compliance review

Peer Compliance Review

Industry sponsors provide monitoring to ensure safety of subjects, data integrity, quality and compliance and they typically have an internal Data Safety Monitoring Plan (DSMP). However, not all sponsors provide study monitoring.   Just because, it is not provided by the sponsor does not mean it should not be completed.   Good documentation drives good clinical research. A competent clinical research coordinator is trained to know, “If it is not documented, it does not exist.”  

Self-monitoring is an important component to ensuring high quality research, especially for studies that are not routinely monitored. Self- monitoring should be implemented in studies not otherwise monitored by sponsors or contract research organizations.  These are most commonly investigator-initiated studies but also include some foundation and federally-funded projects. Use of the self-monitoring tool at least twice a year and more frequently in studies with high accrual or risk to subjects. 

The goal of self-monitoring is to ensure that the following seven elements are evaluated within the research protocol:

  • Subject Safety: monitoring is conducted to avoid or minimize risks (i.e. physical, psychological or social).
  • Data Integrity: monitoring is conducted to ensure data is accurate and complete. Monitoring of data assures adherence to the approved clinical study.
  • Subject Privacy: monitoring is conducted to ensure individual’s rights are protected.
  • Data Confidentiality: monitoring is conducted to ensure data is secured.
  • Product Accountability: monitoring is conducted to ensure drug(s) or device(s) are tracked and accounted for.
  • Study Documentation: monitoring is conducted to ensure that required documentation and reports are on file, accurate and complete.
  • Study Coordination: monitoring is conducted to ensure that investigator delegation and communication with the research team are planned and systematic.

Self-monitoring can be done by a designated internal clinical research compliance auditor or by developing internal checks and balances (e.g. a buddy system among coordinators in the same department).  

Any deviations noted during the review process should be noted through a note to file, and addressed through departmental change processes, policies or the continuing education/retraining of staff on processes and policies. Some might need to be reported to the IRB or have a CAPA created.  

ALCOA-C

During the review the monitoring team should always be vigilant to ensure the study team is following ALCOA-C for their study documentation.  

ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate, Complete)

Acronym for a number of attributes or dimensions considered of universal importance for the data integrity of source data and the records that hold those data. These include that the data and records be:

  • A-Attributable (to both subject and to any actor on a record- monitors should be able to tell who recorded the data, who made a change and why);
  • L-Legible (available for human review, possible to read electronically if an encoded eRecord);
  • C-Contemporaneous (timing of data collection with respect to the time the observation is made: the more promptly an observation is recorded, the better the quality, signatures much come with a date);
  • O-Original (the first suitably accurate and reliable recording of data for the intended purpose);
  • A-Accurate (free from error, especially as the result of care; an accurate diagnosis conforming exactly to truth or to a standard).
  • C- Complete- maintain adequate, accurate and complete source documents at the time of collection do not wait a few days or a week to record

NOTE: ALCOA stems from a talk with Dr. Stan Woollen, the Food and Drug Administration (FDA), in the early 90’s on earmarks for the quality of records and has become a widespread acronym reflecting best practices for clarity and usability of data.

Other Tools and References

The FDA put out guidance for Industry sponsored studies titled A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.

The National Institutes of Health (NIH) states “oversight and monitoring of all intervention studies to ensure the safety of participants and the validity and integrity of the data” is required. NIH policy states "monitoring should be commensurate with risks, size and complexity of the trials.” NIH also emphasizes “the elements of the monitoring plan may vary depending upon the potential risks, complexity, and nature of the trial.”

References: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html (release date June 5, 2000) and http://grants.nih.gov/grants/guide/noticefiles/not98-084.html (release date June 10, 1998).

Many NIH divisions have created templates for different aspects of monitoring/review for studies. 

The Office for Human Research Protection (OHRP) Code of Federal Regulations (45 CFR 46.111) states: “When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.”

Reference: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

The U.S. Food and Drug Administration (FDA) states: "Sponsors of clinical investigations involving human drugs, biological products, medical devices and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare and safety of human subjects and the quality of the clinical trial data submitted to FDA."

Reference: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf

Department of Defense (DoD) Instruction (DoDI) 3216.02 previously required that IRBs approve an independent Research Monitor (RM) with specific roles and responsibilities for all Greater Than Minimal Risk (GTMR) research supported by theDoD. The April 15, 2020 revised DoDI 3216.02 no longer includes the RM requirement