IND/IDE Assistance Program
Clinical Trial Monitoring Activity Templates
– Initial / On-going / Final
These documents are checklists for clinical monitoring activities to ensure that the clinical trial is conducted and documented properly.
They also serve as clinical monitoring reports.
The purposes of clinical trial monitoring are to verify that:
- The rights and well-being of human subjects are protected.
- The reported clinical trial data are accurate, complete, and verifiable from source documents.
- The conduct of the trial is in compliance with the currently approved protocol/amendments, with good clinical practices (GCP), and with applicable regulatory requirements.
For an abridged version of the FDA regulations on the obligations of sponsor-investigators, a copy of the Clinical Monitoring Guidance Document for Sponsor-Investigators, or any other information or assistance regarding investigator sponsored IND applications, contact the IND/IDE Assistance Program at 612-625-0930, , or
Initial Clinical Monitoring Activity
Monitoring responsibilities remain with the sponsor-investigator.
YesNoExplain
The monitor is not a CRO.
YesNoExplain
Name of monitor:
Qualifications of monitor:
There is a written clinical monitoring procedure in place.
Frequency of monitoring activity:
Extent of monitoring activity:
The research staff has been adequately informed about the clinical protocol and investigational drug.
YesNoExplain
The investigational drug is properly labeled and appropriately stored.
YesNoExplain
The investigational drug has been registered with the Investigational Drug Service at Fairview-UniversityMedicalCenter. (612-273-6212)
( Yes No Explain
The IDS registration number is:
There is a drug disposition log.
YesNoExplain
The current clinical protocol has been approved by the IRB Yes (Date) No Explain
The current clinical protocol has been submitted to the FDA. Yes (Date) No Explain
There is a subject recruitment log.
YesNoExplain
There is a subject screening log.
YesNoExplain
There is a case report form.
YesNoExplain
There is a repository for maintaining essential documents.
YesNoExplain
Other observations.
Signature of monitor:
Date:
Reviewed by IND sponsor if not the monitor.
Signature of sponsor:
Date:
If the answer is No to any of these clinical monitoring observations, contact the IND/IDE Assistance Program. (612-625-0930 or )
On-going Clinical Monitoring Activity
Investigational drug is properly stored and disposition log maintained.
YesNoExplain
If there has been any modification to the clinical protocol it has been approved by the IRB prior to its implementation.
Yes (Date)NoExplain
If there has been any modification to the clinical protocol it has been submitted to the FDA prior to its implementation.
Yes (Date)NoExplain
If there has any modification to the clinical protocol the research staff has been informed.
YesNoExplain
The study is being conducted in accordance with the most recently approved study protocol.
YesNoExplain
Written informed consent has been obtained before each subject’s participation.
YesNoExplain
Only eligible subjects are being recruited into the study.
YesNoExplain
The subject recruitment rate is being recorded.
YesNoExplain
Source documents are being kept and are accurate, complete and maintained. Yes No Explain
Required reports have been submitted to the IRB and the FDA.
YesNoExplain
These reports are accurate, complete and timely.
YesNoExplain
Case report forms have been checked for accuracy and completeness.
YesNoExplain
Required data are reported accurately on the case report forms and are consistent with the source documents.
YesNoExplain
Protocol deviations or modifications have been documented and reported to the IRB. Yes No Explain
Adverse events have been documented, investigated and reported to IRB and FDA in the required time periods.
YesNoExplain
Subject’s missed visits, tests, examinations, dosing have been reported on the case report forms.
YesNoExplain
Withdrawals and dropouts of enrolled subjects have been reported and explained on the case report forms.
YesNoExplain
Case report form entry errors, omissions or illegibilities have been corrected, dated, signed and explained (if necessary).
YesNoExplain
Other observations.
Signature of monitor:
Date:
Reviewed by IND sponsor if not the monitor.
Signature of sponsor:
Date:
If the answer is No to any of these clinical monitoring observations, contact the IND/IDE Assistance Program. (612-625-0930 or )
Final Clinical Monitoring Activity
The final study report has been written.
YesNoExplain
A copy of the final study report has been submitted to the IRB.
Yes (Date)NoExplain
A copy of the final study report has been submitted to the FDA.
Yes (Date)NoExplain
The accuracy of the final study report has been compared and verified against the source documents.
YesNoExplain
A complete set of source documents is maintained. (This is fulfilled if the source documents are hospital records.)
YesNoExplain
Other observations.
Signature of monitor:
Date:
Reviewed by IND sponsor if not the monitor.
Signature of sponsor:
Date:
If the answer is No to any of these clinical monitoring observations, contact the IND/IDE Assistance Program. (612-625-0930 or )
Essential Documents Defined
Essential documents are those documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced. These documents serve to demonstrate the compliance of the sponsor-investigator with the standards of GCP and with all applicable regulatory requirements.
Essential documents normally generated before the clinical trial begins:
- Signed protocol and amendments
- Sample case report form
- Sample informed consent form
- Advertisement for subject recruitment, if used
- Signed agreement between S-I and CRO, if applicable
- IRB documentation including committee approval
- Communications with FDA
- CV of investigator and subinvestigators
- Normal values/ranges for medical/laboratory procedures/tests included in the protocol
- Certification/accreditation of laboratory conducting the tests included in the protocol
- Sample label of investigational product
- Drug disposition log
- Decoding procedures for blinded trials, if applicable
- Master randomization list, if applicable
- Trial initiation monitoring report
Essential documents normally generated during the conduct of the clinical trial:
- Revisions to protocol
- CV of new subinvestigators
- Updates to normal values/ranges for medical/laboratory procedures/tests included in the protocol
- Updates to certification/accreditation of laboratory conducting the tests included in the protocol
- Documentation on drug disposition log
- Monitoring visit reports
- Communications with FDA
- Signed informed consent forms
- Source documents
- Signed, dated and completed case report forms
- Documentation of adverse events and related reports
- Interim reports to IRB and FDA
- Subject screening log
- Subject identification code list
- Subject enrollment log
- Investigational product accountability
- Signature sheet
- Record of retained body fluids/tissue samples, if any
Essential documents normally generated after completion or termination of the clinical trial:
- Investigational product accountability
- Documentation of unused investigational product destruction
- Completed subject identification code list
- Final close-out monitoring report
- Treatment decoding documentation, if applicable
- Final report to IRB and FDA
- Report of clinical results and interpretation of trial
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