Organizational Logs

Organization of research data, source documents, and regulatory documents is critical as the study progresses through the sponsor, investigators, research coordinators, monitors, and clinical trial participants. Clinical trial sponsors often provide logs and worksheets to use as supporting documentation to the research data (paper case report forms or electronic data capture). Sponsors may require study teams to periodically submit logs. 

Investigator-initiated research at Emory, without sponsor-provided logs, should still maintain tracking logs that can be used for trending, data analysis, and data verification. Logs should be study-specific with the study title and PI located at the header. Not all logs will apply to every study; utilize the logs provided in this chapter and modify them to align with the protocol. It’s best to use logs at the start of the study. It’s much more difficult to get organized months into the study.

Adverse Event Log

Documenting adverse events can be challenging since AEs exist in multiple places (e.g., physician notes, nursing notes, lab or procedure reports, pill diaries, or email correspondence with a research participant). An AE log serves as the collective source for adverse events to be tracked and analyzed by the investigator and sponsor. AE logs should contain the following fields:

  1. Description of each event
  2. Stop and start dates. Resist the temptation to record “intermittent AE xxx” because recalling the history of the AE will be difficult. AEs will start, stop, and change grade periodically; when that happens, close out the AE with a stop date and make a new AE entry on the log with a new start date.
  3. Grade (according to a pre-defined standard defined in the protocol, for example I-IV or mild-severe)
  4. Action taken by the provider (e.g., additional work-up, medication given or investigational product dose modification)
  5. Whether the event was expected given the known risks of the research or investigational product and the research participant’s medical history/comorbidities
  6. Attribution to the research/investigational product  
  7. Whether the event needs to be reported to the sponsor. If it needs to be reported to the sponsor, provide the date it was reported.
  8. Whether the event needs to be reported to the IRB and if it was, provide the date
  9. Whether the event needs to be reported to the FDA (applicable for sponsor-investigators)

AEs on the log should have supporting source documentation with further detail. Periodically trend AEs to see if they are happening within the expected range of frequency, severity, and duration as described in the informed consent, protocol, and/or investigator’s brochure. If the event trends higher than the expected ranges, then it must be reported to the sponsor, IRB, and/or FDA as a potential unanticipated problem involving risk to participants or others.

Communication log

The communication log can be used as documentation of discussions between individual research participants and research personnel (e.g., phone conversations or other verbal communication).  Maintain the log in the participant’s research record.

The log can also be used to document communication between study team members and sponsors.  Maintain this log in the regulatory binder.

Concomitant Medication Log

The concomitant medication log should contain the name of the medication, start and stop dates, and the reason the medication is being taken. The researcher must refer to the protocol to ensure that the participant is not taking medication that is prohibited by the protocol. If the participant tells the researcher at a later date that he/she has been taking a prohibited medication, consider the protocol requirements and safety profile of the combination of the concomitant medication and the investigational product. Consider the sponsor and IRB’s reporting requirements for protocol deviations.  

Delegation of Authority (DOA) Log

The DOA log documents the PI’s delegation of study related activities across the study team.  It will be the first thing that an auditor will ask to review when arriving on site. The DOA log provides the names of the study team members, the stop and start dates for the research, signatures, and the study activities that have been delegated to them by the PI.

The DOA log should contain a list of the entire study team that has been approved by the IRB. The start date on the DOA log for each individual should not precede that date of IRB approval for that individual or study, CITI/GCP certification, eDisclose completion, or documented study-specific and protocol training.  Ensure that all of these requirements occur before the start date on the DOA log. The DOA log can serve as the final check point before the study team member starts the research.

Enrollment Log

Enrollment logs contain the chronologic enrollment of participants by name, study ID number, and date of enrollment. Additional fields such as eligibility, randomization date, and withdrawal date are also useful to include. The Emory IRB defines enrollment as being the time the participant gives informed consent to participate whether or not the participant goes on to participate in the research Studies that record accrual in Oncore don’t need a separate enrollment log.

Protocol Deviation Log

The federal regulations do not allow for deviations from the protocol unless there is imminent risk of harm to research participants. There are many times though that protocol deviations are unavoidable in clinical trials, whether it be a deviation on the part of the study team or research participant. Protocol deviation logs must contain a description of the deviation, date, corrective action taken, and whether the deviation required reporting to the sponsor or IRB (if so, include the date reported). Deviations should be periodically trended over time to look for systemic problems with the study. Problems for the study should have a thorough root cause analysis and a corrective and preventive action (CAPA) plan.  CAPA plans should be thoughtfully designed, fully implemented, periodically evaluated, and revised as needed to ensure improvement (see CAPA chapter in this guidebook for more information).

Specimen Log

Information regarding specimens collected and stored for clinical trials should be documented on a log.  The specimen log should contain information about what specimen was obtained, method of collection, shipment location (if applicable), and method of storage at Emory (if applicable) including information on the storage conditions (e.g., temperature logs).

References

International Conference of Harmonization, Efficacy Guidelines, Good Clinical Practice