1. Request access to the controlled data sets from the appropriate dbGaP (Database of Genotypes and Phenotypes) Data Access Committee (DAC): https://dbgap.ncbi.nlm.nih.gov/aa/dbgap_request_process.pdf.
2. Download and complete the model Data Use Certification (DUC) for the controlled data set of interest:
   • Visit the dbGAP site at http://www.ncbi.nlm.nih.gov/gap.
   • Search for the study from which data are requested. For example, “joint addiction, aging, mental health” results in number of studies.
   • Click on the linked study title of interest for instructions on how to download the model DUC and determine if IRB approval is required. Model DUC and IRB Requirements can be found under the “Study” tab in the “Authorized Access” section (as shown in screenshot).
     
   • If IRB approval is required, go to the section for “dbGaP Access Request” found at https://ovpr.uchc.edu//rcs/hspp/irb/irb-instructions-forms-and-samples/
     download and complete the form “dbGaP Access Request Form for IRB Certification.”
3. Complete the Data Security and Data Release Form (MS Word)  (PDF).
4. Email the completed Model Data Use Certification, IRB Approval for dbGaP Data Access (if required), and Data Security and Data Release Reporting form to the AVP for Research, Research IT Services – Dr. Khamis Abu-Hasaballah – at khamis@uconn.edu. Upon verification and approval of these documents, the AVP for Research will issue a certification letter signed by him, the Institutional Chief Security Officer, and the Institutional Signing Official (SPS Director).

ResearchMatch.org is a national online recruitment tool for health research, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects health researchers with individuals interested in volunteering, through its secure online matching tool. UConn Health is part of the ResearchMatch Network. There is no cost to UConn Health researchers to use ResearchMatch. There are currently over 120,000 registered volunteers across the country. ResearchMatch is also available in Spanish.

Register now to see if ResearchMatch might be a useful recruitment tool for your health-outcomes research study:

Use this link to register as a researcher: https://www.researchmatch.org/researchers/. You do not need to be a Principal Investigator to register. The registration process takes less than 10 minutes and when you are finished, you will be granted “feasibility access” to do a feasibility search of aggregate data regarding the current ResearchMatch volunteer population. You will be able to see the demographic and health information breakdown for the volunteers within a designated geographic area.

If you decide to use ResearchMatch to conduct participant recruitment, you will need IRB approval:

1. The Vanderbilt IRB provides oversight for ResearchMatch as a recruitment tool and this has been documented within the ResearchMatch IRB Letter of Understanding (available upon request), but to use ResearchMatch as a recruitment tool for a specific study, you will first need to get UConn Health IRB approval.
   1. For the IRB submission, the following language may be used to describe ResearchMatch as a recruitment method: Potential volunteers will be contacted by ResearchMatch via an email contact message containing IRB-approved recruitment language for this study (not including direct study contact information such as study phone number). Volunteers will then have the option of replying by clicking ‘yes’ or ‘no’  in the contact message. If a volunteer chooses to respond in the affirmative, they will authorize ResearchMatch to release their contact information to the PI (or ResearchMatch designee) who will be responsible for managing that information according to institutional guidelines.
   2. The contact message consists of the language to be used in the email sent by ResearchMatch on your behalf to potential participants. Please note that your contact message must not include your direct study contact information (email or phone), and must not exceed 2000 characters. If the study involves in-person participation, you may want to include the geographical location of the study site. If you intend to include healthy controls, specify that in your contact message, otherwise, a healthy control volunteer may decline participation. Please see contact message examples provided by ResearchMatch as well as this form that offers additional tips for creating an effective contact message.
2. Once ResearchMatch is an IRB-approved recruitment method, you may then register as a researcher to request “recruitment access” in ResearchMatch. You will need to upload your IRB approval letter and your IRB-approved contact message. Recruitment access will give you the ability to send your contact message to potential participants that you select. If a potential participant agrees, you will then have access to his/her contact information in order to contact about possible study participation.

 

 

For questions about how to use ResearchMatch for your health research, please contact ResearchMatch Liaison, Ellen Ciesielski, eciesielski@uchc.edu.

To register your study on ClinicalTrials.gov:

1. 1. Request the creation of a user account for the ClinicalTrials.gov Protocol Registration and Results System (PRS) by emailing Ellen Ciesielski, UConn/UConn Health’s ClinicalTrials.gov Administrator.
      • A record can have only one “Owner” who may be the Principal Investigator (PI) or may be someone designated by the PI to create/update the record on his/her behalf. The PI will always log in to perform the final review and approval of the record and each subsequent update.
   2. Receive your username and a temporary password by automated email from the PRS System.
   3. Go to the Clinicaltrials.gov Registration log-in page to enter your username, password and Organization. If you are a UConn Health investigator, in the Organization field, enter “UConnHealth” (no spaces). If you are a UConn Storrs or Regional Campus investigator, in the Organization field, enter “UConn.”
   4. On the Main Menu page, under “Records” click on “New Record” from the drop down menu. The system will walk you through the creation of your record, section by section. On each page, select “Continue” to save data entered and proceed to the next page. On any page, select “Quit” to stop entering data. Data entered on previous pages will be retained so that you can return to complete the record at a later date.

As the PI, or PI designee, you are the Record Owner and are responsible for entering accurate information about your trial and updating the information in a timely manner (see table below for specific deadlines).

Complete the below fields as follows:

1. 1. • Organization’s Unique Protocol ID: Enter the IRB number.
      • Secondary IDs: Enter the grant number.
      • Record Verification Date: Enter the month and year in which you are completing the record. This field will need to be updated each time you update the record after it is registered.
      • Primary Completion Date: Enter the anticipated final data collection date, specifically regarding the Primary Outcome Measure.
      • Responsible Party: Select the Principal Investigator from the drop down menu.
      • Collaborators: Add any other organizations providing support, including funding, design, implementation, data analysis and reporting.

Investigators from UConn Health:

1. 1. • Board Name: UConn Health IRB
      • Board Affiliation: UConn Health
      • Board Contact phone and e-mail: Enter your study’s IRB panel Coordinator contact information
        • Stephen MacKinnon mackinnon@uchc.edu 860.679.8729 (Panel 1 and new expedited/exempt submissions, facilitated reviews)
        • Patricia Gneiting gneiting@uchc.edu 860.679.4849 (Panel 2 and new expedited/exempt submissions, facilitated reviews)
      • Board Contact Address:  UConn Health IRB, 263 Farmington Avenue, Farmington, CT 06030-1511

Investigators from University of Connecticut Storrs and Regional Campuses:

1. 1. • Board Name: University of Connecticut IRB
      • Board Affiliation: University of Connecticut
      • Board Contact phone and e-mail: Doug Bradway doug.bradway@uconn.edu 860.486.0986
      • Board Contact Address: UConn IRB, 438 Whitney Road Extension, Unit 1246, Storrs, CT 06269

To remain in compliance with the Final Rule, update the data fields on the scheduled detailed in the table:

Data Field	Deadline for Updating (i.e., not later than the specified date)
Study Start Date	30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).
Intervention Name(s)	30 calendar days after a nonproprietary name is established.
Availability of Expanded Access	30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record.
Expanded Access Status	30 calendar days after a change in the availability of expanded access.
Expanded Access Type	30 calendar days after a change in the type(s) of available expanded access.
Overall Recruitment Status	30 calendar days after a change in overall recruitment status. If Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Why Study Stopped data element must be submitted at the time the update is made.
Individual Site Status	30 calendar days after a change in status of any individual site.
Human Subjects Protection Review Board Status	30 calendar days after a change in status.
Primary Completion Date	30 calendar days after the clinical trial reaches its actual primary completion date.
Enrollment	At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted.
Study Completion Date	30 calendar days after the clinical trial reaches its actual study completion date.
Responsible Party, by Official Title	30 calendar days after a change in the responsible party or the official title of the responsible party.
Responsible Party Contact Information	30 calendar days after a change in the responsible party or the contact information for the responsible party.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Record Verification Date	Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

To register your trial:

1. 1. Request an account for the ClinicalTrials.gov Protocol Registration and Results System by emailing the local ClinicalTrials.gov Administrator, Ellen Ciesielski.  The message should be sent by the person who will be creating the Protocol Record for a clinical trial, i.e., the PI or the PI’s designee. A Protocol Record can have only one “Owner.”
   2. Receive by automated email a login name and a temporary password.
   3. Go to the Clinicaltrials.gov website.
   4. Complete the login fields. If you are a UConn Health investigator, in the “Organization” field, type “UConnHealth.” If you are a UConn Storrs or Regional Campus investigator, in the “Organization field, type “UConn.”
   5. Browse the Main Menu page. Under “User Account,” follow the instructions for changing your temporary password as soon as possible. Save your password; you will need it for periodic updates and verification. Under “Help”, refer to the “User’s Guide” for additional information. As the PI, or PI designee, you are a User and are responsible for entering the information about your trial, ensuring that the information is correct, and updating the information in a timely manner (for updating, see NOTE at the end of this section).
   6. On the Main Menu page, under “Protocol Record” click on “Create” and complete the study description template. Note that required fields are marked with
      • * [a red asterisk] = required by ClinicalTrials.gov
      • FDAAA [in green] = required to comply with US Public Law 110-85, Section 801
      • (FDAAA) [in green] = may be required to comply with US Public Law 110-85, Section 801

Work your way through the data fields to complete the Protocol Record. Data are saved as each screen is filled in, so that you can “Quit” at any time, saving the Record for later completion using “Modify.”

Complete the following fields as follows:

1. 1. • Organization’s Unique Protocol ID: Use the IRB number.
      • Secondary ID: Use the grant number.

Investigators from UConn Health:

1. 1. • Board Name: Use UConn Health IRB
      • Board Affiliation: Use UConn Health
      • Board Contact E-Mail and phone: Use your study’s IRB panel Coordinator
        • Pam Colwell – engelson@uchc.edu, 860-679-1019 (Panel 1 and CICATS and new expedited/exempt submissions)
        • Patricia Gneiting – gneiting@uchc.edu, 860-679-4849 (Panel 2 and new expedited/exempt submissions, facilitated reviews)
      • Board Contact Address:  UConn Health IRB, 263 Farmington Avenue, Farmington, CT 06030-1511

Investigators from University of Connecticut Storrs and Regional Campuses:

1. 1. • Board Name: use University of Connecticut IRB
      • Board Affiliation: use University of Connecticut
      • Board Contact E-Mail: doug.bradway@uconn.edu
      • Board Contact Phone: (860) 486-0986
      • Board Contact Address: UConn IRB, 438 Whitney Road Extension, Unit 1246, Storrs, CT 06269

Investigators from UConn Health and University of Connecticut Storrs and Regional Campuses:

1. 1. • Oversight Authorities: If this is not an FDA-regulated protocol, state “United States: IRB”
      • Collaborators: Other organizations (if any) providing support, including funding, design, implementation, data analysis and reporting.
      • Record Verification Date: Enter the month and year in which you are completing the record. This field will need to be updated each time you update the record after it is registered.
      • Primary Completion Date: final data collection date, specifically regarding the Primary Outcome Measure
      • Responsible Party: The Principal Investigator should be listed as the Responsible Party.
      • Specifying Study Arms: along with Data Definitions, help is available at https://prsinfo.clinicaltrials.gov/definitions.html#Arms
      • Conditions: Use the MeSH controlled vocabulary. If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.
      • Keywords: Use the MeSH controlled vocabulary. If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.
      • Investigators: list all investigators on the approved IRB protocol.

Automatic messages from the electronic system:

1. 1. • WARNING: indicates a data element required by the FDA Amendments Act of 2007 has not been entered.
      • ERROR: indicates a serious problem that needs to be addressed
      • ALERT: indicates a problem that needs to be addressed; generally that problem is a missing data element required by ICMJE
      • NOTE: indicates a potential problem that should be reviewed and corrected, as needed
      • Protocol Records must be free of the first three messages in order to be approved and released to ClinicalTrials.gov for processing and publication

To maintain your record and remain in compliance with the Final Rule, you must update the data fields on the schedule detailed in the table:

Data Field	Deadline for Updating (i.e., not later than the specified date)
Study Start Date	30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).
Intervention Name(s)	30 calendar days after a nonproprietary name is established.
Availability of Expanded Access	30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record. [1]
Expanded Access Status	30 calendar days after a change in the availability of expanded access.
Expanded Access Type	30 calendar days after a change in the type(s) of available expanded access.
Overall Recruitment Status	30 calendar days after a change in overall recruitment status. [2]
Individual Site Status	30 calendar days after a change in status of any individual site.
Human Subjects Protection Review Board Status	30 calendar days after a change in status.
Primary Completion Date	30 calendar days after the clinical trial reaches its actual primary completion date.
Enrollment	At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted.
Study Completion Date	30 calendar days after the clinical trial reaches its actual study completion date.
Responsible Party, by Official Title	30 calendar days after a change in the responsible party or the official title of the responsible party.
Responsible Party Contact Information	30 calendar days after a change in the responsible party or the contact information for the responsible party.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Record Verification Date	Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

Over the past ten years, government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinical trials are publicly available. The registration effort began with the development of a publicly available website, ClinicalTrials.gov, a service of the National Institutes of Health (NIH), developed by the National Library of Congress.

In 1997, the Food and Drug Administration (FDA)/NIH began requiring registration for only a limited number of trials. Then in September 2007, the FDA Amendments Act (Title VIII. Sec. 801) significantly expanded the scope of clinical trials that must be registered and set civil monetary penalties for failing to register “applicable trials.” In 2004, the ICMJE defined trials that must be registered in order to be considered for publication in journals that adhere to ICMJE standards. In 2007, the ICMJE expanded the definition of trials that must be registered. Scores of journals (not limited to medical journals) have adopted the registration policy. In 2016, the final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), which clarifies and expands the requirements in FDAAA 801, was released, and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information was published.

The bottom line:
The FDA, NIH and the ICMJE each have their own requirements for registration, and while some of the requirements overlap, there are some differences. In order to comply with the law and preserve the ability to publish in many journals, all sets of requirements must be met. UConn is committed to compliance with the regulations of the FDA, NIH and ICMJE in supporting Principal Investigators (PIs) with meeting the requirements concerning the public availability of clinical trial data in ClinicalTrials.gov, as outlined in our University ClinicalTrials.gov policy.

How is “clinical trial” defined and what are the registration deadlines?

According to NIH:

A clinical trial is a research study¹  in which one or more human subjects² are prospectively assigned³ to one or more interventions⁴ (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.⁵  All clinical trials must be registered within 21 days of enrollment of the first participant.

¹See Common Rule definition of research at 45 CFR 46.102(d).

²See Common Rule definition of human subject at 45 CFR 46.102(f).

³The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

⁴An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

⁵Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

Registration Deadline: The NIH Policy on Dissemination of NIH-funded Clinical Trial Information applies to applications for funding submitted to NIH on or after 1/18/17. Registration is required no later than 21 days after the first patient is enrolled. The consent form for the trial is required to include the following language: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 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.”

According to the ICMJE:

A clinical trial is any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.

Registration Deadline: Registration at or before the time of first patient enrollment is as a condition of consideration for publication in an ICMJE journal.

According to the FDA:

The U.S. Department of Health and Human Services in September 2016 issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological, and device products. The FDA Amendments Act (Title VIII. Sec. 801) requires registration for all “applicable clinical trials,” including Federal, industry-sponsored, and investigator-initiated that are:

1. Trials of drugs and biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation, and
2. Trials of devices: Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human subjects (other than small clinical trials to determine the feasibility of a device, or clinical trials to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and pediatric postmarket surveillance studies, as required under the Federal Food, Drug and Cosmetic Act.

Registration Deadline: The FDA Amendments Act of 2007 requires that all trials, regardless of sponsor, must be registered in full no later than 21 days after the first patient was enrolled.

Who is responsible for registering a trial?

The PI is ultimately responsible for determining that registration requirements are met. Although some industry sponsors will do the actual registration work, it is still the PI’s responsibility to ensure that the registration has been accomplished and is accurate.

What are the penalties for failing to register?

According to the ICMJE:

Unregistered trials will not be considered for publication in journals that adhere to ICMJE standards. Questions about policies of a specific journal should be addressed to that journal directly. A list of journals whose editors or publishers have signed on to the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals may be found at http://www.icmje.org/journals.html.

According to the FDA/NIH:

Penalties may include civil monetary penalties up to $14,724 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $14,724 per day until resolved. For federally funded grants, penalties may include the withholding or recovery of grant funds.

Who can help with questions about meeting the requirements?

To comply with University policy regarding ClinicalTrials.gov, please direct any questions to the local Protocol Registration and Results System (PRS) Administrator for UConn/UConn Health, Ellen Ciesielski, Office of the Vice President for Research, Research Integrity & Compliance at 860.679.6004 for any questions related to ClinicalTrials.gov. The PRS Administrator serves as a point of contact for resolving requests by ClinicalTrials.gov and regularly monitors to promote compliance with the requirements.

 

 

Research IT Services in the Office of the Vice President for Research supports a wide array of services and is a key player in shaping the future of research at the University of Connecticut.

We have embarked on a bold initiative to modernize and boost our portfolio of software solutions in an effort to reduce the administrative burdens on our researchers and make it easier for them to access and monitor their research activity and information.

A full suite of enterprise applications will provide a template for grant proposal development, automate routing and allow for electronic submission to certain sponsors. In addition, it will provide functionality for awards management; human and animal subjects protocol development and review; financial conflict of interest disclosures; effort reporting and commitment management; and core facility management (research store).

eRA Help Desk

We have coined our initiative to modernize our Enterprise Research IT systems and automate research administration functions the electronic Research Administration, or eRA. We have created the eRA Help Desk to assist you with your questions and technical problems. The eRA Help Desk’s contact information is listed below.

eRA Help Desk

Telephone: 860-486-7944
Email: eRA-support@uconn.edu
Staffed 8:00 AM – 4:30 PM Weekdays

Self-Service Portal: https://it.research.uconn.edu/SelfService (secured with UConn NetID) Don’t know your NetID?

Name	Title	Phone	Email
Michael Centola, MHS, CIP	Associate Vice President for Research Integrity	860.205.3702	centola@uchc.edu
Ellen Ciesielski	Research Compliance Monitor	860.679.6004	eciesielski@uchc.edu

 

Name	Title	Phone	Email
Bieu Tran	Export Control Officer	860.486.3994	bieu.tran@uconn.edu
Export Control	General Mailbox	860.486.3994	exportcontrol@uconn.edu