Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors
Phase: PHASE2
Conditions: Neuroendocrine Tumors, Von Hippel-Lindau Syndrome, Hippel-Lindau Disease
Sponsor: National Cancer Institute (NCI)

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Clinical Investigation Monitoring Worksheet 
For Protocols using PET IND Radiopharmaceuticals 
 
 
NIH /CC/PET Department 
The Food and Drug Administration (FDA) and the NIH Intramural Research Program require that 
the Positron Emission Tomography (PET) Department, NIH Clinical Center, ensures that every 
clinical research study performed using an IND it sponsors, has an adequate monitoring plan of 
the clinical investigation. 
 
The Investigator can choose to follow their IC Guidelines/SOP to monitor the clinical 
investigation, or due to the “Low Risk” categorization of observational studies that use PET IND 
Radiopharmaceuticals, choose to conduct an annual monitoring of the clinical investigation by 
completing the following worksheet. The monitoring worksheet may be completed at the time 
of Continuing Review by the Principal Investigator or a designee (designee must be familiar with 
the study. Completed worksheet must be signed by the PI.  
 
This worksheet is designed to assist investigators to conduct basic monitoring of their clinical 
investigation and identify areas where quality improvement may be needed. The key elements 
incorporated into this monitoring worksheet are protocol compliance, patient safety, and 
quality improvement.  
 
Please complete, sign and return worksheet to the Tara Norouzi at the PET Department: 
Tara Norouzi NIH/CC/PET 
10 Center Drive, MSC1180 (Rm 1C-482) Bethesda, MD  20892   
Phone: 301-435-8505  Fax: 301-480-5695 . norouzit@cc.nih.gov 
 
Definitions 
AE 
Any untoward medical occurrence associated with the use of a drug in humans, whether or not 
considered drug related 
SAE 
A serious adverse drug experience, resulting in death, life-threatening adverse drug experience, 
hospitalization, disability or congenital abnormality 
Source Documents 
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory 
notes, memoranda, evaluation checklists, pharmacy dispensing records, recorded data from 
automated, x-rays, subject files) 
CRFs 
Case Report Forms are printed, optical, or electronic document(s) designed to record all of the 
protocol-required information. On-site monitoring should identify data entry errors (e.g., 
discrepancies between Source Documents and CRFs) and provide assurance that there are no 
missing data in source documents or CRFs 
CAPA  
Corrective And Preventive Action  
Deviation 
Any alteration/modification to the IRB-approved protocol 
Site Signature and 
Delegation Log 
A document that contains a list of all research staff involved in the conduct of the study, 
signatures, initials, delegated tasks and effective dates 
 

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GENERAL INFORMATION 
 
Protocol Number:  
 
Rad Auth Number (if available):   
Investigational Drug(s): 
 
IND Sponsor: 
PET Department, NIH 
Protocol Title:  
 
 
 
Principal Investigator (PI):  
 
Reporting Period (covering this 
monitoring report) 
 
Date(s) Monitoring Conducted: 
 
Name of Monitoring Personnel: 
Job Title: 
Contact (Telephone): 
 
 
 
 
 
 
 
 
 
 
MONITORING CRITERIA (Choose option A or B) 
 
Option A 
         Annual Worksheet   (complete this monitoring worksheet)         
 
______________ Total No. of participating subjects in this reporting period       
 
______________ No. of subject files randomly chosen to be monitored by this worksheet  
                           (Monitoring of 10% of total No. of participating subject annually is recommended)  
STATEMENTS OF COMPLIANCE 
I understand and endorse the information in this clinical investigation monitoring worksheet.  I 
agree to notify the IND sponsor if any of the information provided in this worksheet is amended.   
                  THIS WORKSHEET MUST BE SIGNED BY THE PRINCIPAL INVESTIGATOR  
Investigator’s signature 
 
 
 
Date 
 
 
Option B 
 

Monitoring was conducted Per IC Requirements  
                         (provide IC monitoring report to IND sponsor) 
 

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NOTE: THIS WORKSHEET MUST BE SIGNED BY THE PRINCIPAL INVESTIGATOR. 
 
ESSENTIAL CLINICAL MONITORING ELEMENTS  
SUBJECT OR FILE IDENTIFICATION No. _________________ 
(This form must be completed for each subject file that is selected to be monitored) 
 
 
13 File Management                                                                                               * Response requires CAPA 
1 Is the most recent protocol version available? 
Yes    No * 
2 If yes, state the protocol version 
Version # _______________ 
3 Is a signed FDA Form 1572 and Financial Disclosure 
documentation available? 
Yes    No *
4 Is there a Site Signature and Delegation Log? 
Yes    No *
5 Is there a document that assures IRB approval was 
obtained prior to enrollment of the subjects in the 
study? 
Yes    No * 
 
14 Safety                                                                                                                  * Response requires CAPA 
6 
Were there any occurrences of AE or SAE’s? 
Yes    No  
 
(If “Yes” complete 7-9, if “No” skip 7-9)  
 
7 
Was AE/SAE Investigated and documented? 
Yes    No *                        
8 
Was AE/SAE Reported to IRB? 
Yes    No *    
9 
Was AE/SAE Reported to IND Sponsor? 
Yes    No *   
10 Was there any AE/SAE that was missed and not 
reported? 
Yes*  No 
11 Were there any deviations to the protocol? 
Yes    No  
12 If “Yes” was deviation reported the IRB and 
Sponsor? 
Yes    No * 
 
15  Consent Form                                                                                                    * Response requires CAPA 
13 Was a consent form obtained? 
Yes    No *
14 If yes, was the most current IRB approved 
consent form used? 
Yes    No *
15 If yes, what is the expiration date of the consent 
form? 
Date Consent form filled out_________ 
Exp. Date of Consent form __________ 
16 Was the consent form signed and dated by 
patient or guardian? 
Yes    No *
17 Was the subject’s signature/date on consent 
form prior to initiation of the study-specific 
procedure(s)? 
Yes    No *

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18 Was a copy of the signed consent given to 
subject?  
Yes    No *
19 If yes, is there documentation in the subject’s 
medical record that the copy was given? 
Yes    No * 
16 Subject Records (Patient Study Binder)                                                       * Response requires CAPA 
20 Are Source Documents available and reviewed? 
Yes    No *
21 If applicable, are the CRFs available and verified to 
ensure accuracy with the source documents? 
Yes    No *    N /A  
22 Was the PET Radiopharmaceutical administered 
per protocol specifications? 
Yes    No *
23 Is there a document that lists inclusion / exclusion 
criteria? 
Yes    No *
24 Did the subject enrolled meet all inclusion / 
exclusion criteria? 
Yes    No *
25 Has the subject missed any visits specified in the 
protocol? 
Yes    No 
26 If yes, were the missed visits and the reason 
documented? 
Yes    No *
 
 
 
CAPA (CORRECTIVE AND PREVENTIVE ACTION) 
List actions taken to correct deficiencies as a result of this monitoring. This is a tool for quality 
improvement. Attach additional pages if needed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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