University of Pittsburgh ECO Monitoring Checklist

Sponsor-Investigator:______

______

Study Reviewed:______

IND/IDE#______

IRB#______

UPCI#

(if applicable)______

Reviewers:______

Review Date:______

# Subjects Enrolled

To Date:______

# Subjects Enrolled

During This Monitoring

Period______

Number of modifications to date:______

Number of Reportable events to date:______

1.Regulatory Files / Essential Documents of Investigator File

Yes / No / NA
1. Regulatory documents organized, complete, available
1.1IND - FDA 1572 current, signed, dated, complete, correct
1.2IDE – investigator agreement
1.3 FDA acceptance letter / comments
Has the sponsor / investigator appropriately responded to any comments / questions
raised by FDA?
1.4 Required CV’s and license on file
Advisable: all staff involved in the treatment and/or
evaluation of study subjects and all persons listed on the 1572 orinvestigator agreement
1.5 Financial disclosure forms completed by each listed investigator and sub-
investigator involved in subject treatment and/or evaluation
1.6 Clinical laboratory certifications and normal ranges present
1.7 Protocol and accompanying instruction manual (if any) available and current
1.8 Clinical protocol amendments on file – respective modifications submitted for IRB
review / approval and FDA review if applicable
1.9 IND Annual Reports or IDE Progress Reports
1.10 Investigator list provided to the FDA at 6 month intervals (IDE)
1.11 Notes from Data Safety Monitoring Plan / Committee meetings
1.12 Investigator’s brochureor drug packaging information (IND) or report of prior investigations(IDE)
1.13 Has there been a change in the drug supplier?
1.14 Has the investigator and other appropriate study team members completed the CITI GCP
Training and is the certificate on file? (CITI)
Should be completed by all study team members who are involved in the treatment and/or
evaluation of study subjects in an FDA-regulated study
1.15 Did the compliance staff review (at the first visit) the O3IS sponsor-investigator responsibilitiesdocument with the appropriate parties?
COMMENTS: Please comment on all significant findings:

2.Subject Consent

Yes / No / NA
2. Signed consent form for each subject
2.1 Original signed consent present in subject file
2.2 Subjects signed revised consent / addendum consent when required
e.g., changes to risk / benefit ratio, new information added
2.3 Consent forms signed and dated per FDA and IRB policy
a. Subject, parent or proxy
b. Physician investigator who is listed on first page of consent document
(waivers granted?)
c. Each signatory dated his / her own signature
2.4 Consent obtained prior to study procedures
2.5 Consent process documented in progress notes / source documents
2.6 Documentation of assent process (if applicable)
2.7 Verification of parental status (if applicable)
COMMENTS: Please comment on all significant findings:
Number of consent forms reviewed______

3. Protocol Adherence

Yes / No / NA
3.1 Do study-specificorders and case report forms correspond with protocol, consent form
and other study documents?
3.2 Documentation present to validate that each subject met eligibility criteria
Study-specific eligibility criteria checklist
3.3 Documentation present for completion of all study procedures
Subject records are readily available (i.e., all source documents retrievable)
Clinical laboratory results documented, available and signed
Abnormal results addressed
3.4 Were any unreported protocol deviations noted at this visit?
3.5 Were there any self -reported deviations?
If any self- reported deviations require ECO attention or additional corrective actions, please note in comment sections.
3.6 Documentation present to indicate reasons for withdrawn subjects
3.7 Data corrections made appropriately
3.8 Were substantive changes necessary to the ECO-HSR monitoring forms since previous
visit ?
If so, please describe below:
3.9 Were significant issues identified which were missed at the previous monitoring visit?
If so, please describe below:
3.10 Were there any areas of repeated non-compliance?
If so, please describe below:
COMMENTS: Please comment on all significant findings:
Number of subjects evaluated______
Number of subjects with questionable eligibility______
Number of instances study procedures were not done as per protocol______

4. Safety Monitoring

Yes / No / NA
4.1 Were adverse events recorded?
Medically significant study events noted in subject’s record
4.2 Were adverse events followed up appropriately?
4.3 Were there any serious adverse events?
4.4 Were there any serious adverse events that met IRB / FDA reporting requirements?
4.5 Was the sponsor notified as required per protocol?
4.6 Were DSMP meetings held per protocol?
Documentation of meetings present
4.7 Were there any changes to risk / benefit ratio?
4.8 Were any unanticipated problemsidentified at this visit?
Describe in comment section below
4.9 Were there any self-reported unanticipated problems?
If so describe in comment section.
COMMENTS: Please comment on all significant findings:

5.0 Institutional Review Board

Yes / No / NA
5.1 Prospective IRB approval of protocol and consent form modifications
5.2 Continuing IRB review obtained
5.3 IRB approval of advertising, printed recruitment materials and other subject information (e.g., subject teaching materials)
COMMENTS: Please comment on all significant findings:

6. Drug or Device Accountability and Handling

Note: If investigator is using the Investigational Drug Service, note this in the comments section and skip to next section.

Yes / No / NA
6.1 Is the investigator using IDS? If so, skip this section.
6.2 Storage conditions / monitoring methods per protocol
Secure storage area
6.3 Records of receipt
6.4 Records of subject dispensing and returns
6.5 Documentation of transfers, i.e., chain of custody
6.6 Records of disposition
COMMENTS: Please comment on all significant findings:

7.0 Clinical Trials.gov

“Applicable clinical trials” are required by federal law to be registered in ClinicalTrials.gov.

Applicable Clinical Trials include:

  • Trials of drugs and biologics: Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation.
  • Trials of devices: A prospective clinical study of health outcomes, other than a small clinical trial to determine the feasibility of a device, that compares an intervention with a device against a control in human subjects and is subject to section 510 (K), 515 or 520 (m) of the FDC Act or is a pediatric postmarket surveillance study.

The NIH strongly encourages registration of all clinical trials, even if registration is not required by law. If PIs are unsure if a study is an “applicable clinical trial” they are encouraged to register the study. Studies must be registered in full prior to enrollment of the first subject (verified by having a “NCT” number).

In addition, to promote transparency of the clinical trials process, the International Committee of Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a public registry prior to subject enrollment as a condition of consideration for publication of the trial results.

Has the investigator answered “yes” to the study being an “Applicable Clinical Trial”? If so, then complete the following table.

Yes / No / NA
7.1 Has the sponsor completed registration of the protocol on clinicaltrials.gov?
If yes, list “First Received” date: ______
7.2 Was the registration date within 21 days of the first subject being enrolled?
7.3 Does the informed consent document contain the following mandatory language?
A description of this clinical trial will be available on , as required by US Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
7.4 When was the record last verified? List date: ______
Is the verification date within one year of the current date?
7.5 Were there any changes to the IRB approved protocol that require modifications to Clinicaltrials.gov, e.g. projected enrollment, assigned intervention, subject eligibility, the research plan or methods?
7.6 Is the estimated study completion date consistent with the current enrollment plans of the investigator?
7.7 If subject enrollment is completed, is the estimated primary completion date consistent with the date that the final data for the primary outcome measure was collected for the last subject?
COMMENTS: Please comment on all significant findings:
Investigator Name / CV / Lic / FD
(C – Certification)
(D – Disclosure)
(N – Notification) / Training / DAL / Current
1572 / Comment

Timelines

Date / INDActivity
Date / IRB Activity

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