Organizational Logs

Clinical trial sponsors will often supply logs or worksheets to the study team to use as supporting documentation to the case report forms or as the actual case report forms (this is often seen with electronic data capture). Sponsors may require study teams to periodically submit logs to them.

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 in case of an audit. Logs should be study-specific with the study title and PI located at the header. Not all logs will apply to every study, but when applicable, we encourage you use the logs provided and to modify them to fit your needs.

Adverse Event Log

Adverse Events and their documentation are very important for human subject protection as well as data integrity. An AE log serves as the collective source for adverse events that exist in multiple places (e.g., physician notes, nursing notes, lab or procedure reports, pill diaries, or email correspondence with a research subject).  AE logs must contain a description of each event, stop and start dates, action taken by the provider (e.g., additional work-up, medication given or investigational product dose modification), grade (according to a pre-defined standard, for example I-IV), and attribution to the investigational product.  Including additional checkboxes on the AE log for each event regarding whether the event was reported to the sponsor, IRB, and/or FDA, are helpful as well. 

AEs on the log should have supporting source documentation with further detail.  Don’t forget to report AEs to the sponsor, IRB, and FDA as required by their policies and federal regulations.

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 subjects or others.

For more information on AEs, see the CTAC AE Guidance and IRB website

View the AE Log

Concomitant Medication Log

The concomitant medication log must 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 subject is not taking medication that is prohibited from the protocol.  If the subject 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.  

View the Concomitant Medication Log

Delegation of Authority (DOA) Log

The DOA log is one of the most critical logs you will maintain.  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, their 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 certification, eCOI completion, or documented study-specific training.  Be sure that all of these requirements occur before the start date on the DOA log. The DOA log can serve as the last point or check point before the study team member starts the research.

View the DOA Log

Enrollment Log

Your enrollment log will contain the chronologic enrollment of subjects by name and number.  It will incorporate the subject’s identifier (name or initials), study subject number, and date of enrollment.  You may also want to include additional fields such as eligibility, randomization date, and withdrawal date.  Remember that the Emory IRB defines enrollment as being the time the subject gives informed consent to participate.

View the 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 subjects.  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 subject.  Protocol deviation logs must contain a description of the deviation, date, corrective action taken, and to whom the deviation was reported (e.g., sponsor or IRB) and when.  Deviations should be periodically trended over time to look for systemic problems with the study.  Problems for the study should have a thoughtful root cause analysis of the problems and a corrective and preventive action (CAPA) plan in place.  CAPA plans should be thoughtfully designed, fully implemented, periodically evaluated, and revised as needed to ensure improvement.

View the Protocol Deviation Log

Specimen Log

Information regarding specimens obtained and stored for clinical trials should be documented on a log.  The specimen log should obtain information about what specimen was taken, how it was obtained, where it was shipped to (if applicable), and how it was stored at Emory (if applicable) including information on the storage conditions (e.g., temperature logs).

View the Specimen Log