- About Us
- The UMDNJ Health System
- Research Profiles by School
- Industry Collaborators
- Our Investigators
- Interested Participants
- Find Clinical Trials
- Contact Us
- Submitting Agreement/Document to Legal Management
- Do you need help to start a study?
- ClinicalTrials.Gov Submission- What to know
- The IND 1571 and IND 1572 - FDA Investigational Drug Forms
- The IDE- Investigational Device exemption
- IRB Submission: WIRB
- Recruitment and CenterWatch.com
- Good Clinical Practice
- UMDNJ Clinical Trials Policy, Other Research Policies and Indirect Cost Rate
- Export Controls and Research Publication
- Quality Improvement - Self-Assessment Guide to Study Management
- The UMDNJ CRO Discussion Board
- Submitting Clinical Trial Opportunities to CenterWatch.com Online Database
- Online Training Resources
- Funding Resources
- Financial Conflict of Interest
1. Submit an agreement or document to Legal Management for Review
You may submit a Confidentiality Disclosure Agreement, Non-Disclosure Agreement, Clinical Trial Agreement, a Sub-Award Agreement or other research document to Legal Management through the following link:
All documents must be submitted in Word format and only UMDNJ faculty or staff may submit. To submit your document, you will need to provide at least the following information:
- Title of Project
- Name of Sponsor
- Phone, Address and Email of Sponsor/Sponsor Contact
Frequently Asked Questions (FAQ):
- Why do I have to send so much information? This is the same information that has always been requested by legal in order to complete work on a new agreement. Having all of the information in one place at the beginning will help to speed the process by preventing unnecessary delays associated with requests for additional information.
- Who should submit this form? The form can be submitted by the Investigator, the Study Coordinator or administrative personnel either assigned to the project or from the Department. However, it is important that the task be assigned to one person in order to prevent duplicate entries. This link is intended for use by UMDNJ employees only. It should not be used by the Sponsor or other 3rd parties to submit new documents to legal for review.
- Why is this better than just sending the document to the person I know in Legal who I have always worked with? Having all of the documents enter the process in the same place makes it easier to keep track of them, speeds up the entry process, makes it possible to balance attorney workload, prevents documents from being lost, and provides a way to have transition coverage in case someone leaves or goes on vacation.
- When I submit my document for the study, what should I expect? You should expect to receive an email in 3-5 business days confirming the receipt of the document and providing you with the file number and the responsible attorney.
2. Do you need help to start a study?
Click HERE for FAQs (frequently asked questions) regarding study startup. These questions cover the 4 major components of starting a study:
- UMDNJ Forms
The FDA has an excellent section specifically for understanding clinical trials: Running Clinical Trials: FDA Requirements, Guidelines and Resources - A Comprehensive Review.
3. ClinicalTrials.gov Submission - What to Know
The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85), passed on September 27, 2007, requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. This registration goes into the national clinical trials database, entitled "ClincialTrials.gov."
ClinicalTrials.gov facilitates registration of trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative, requiring prior entry of clinical trials in a public registry as a condition for publication.
- The trial must be posted within 21 days of enrolling the first patient.
- The sponsor may be responsible for submitting the trial.
- If the sponsor states that the trial has already been registered, check the information about your trial on ClinicalTrials.gov, e.g., for multi-site studies, be sure that your site is listed and that the information is accurate.
- If the sponsor intends to register the trial, be sure that registration occurs before you enroll your first subject. Once the trial has been registered, check the record for accuracy.
- UMDNJ Frequently Asked Questions
- Another helpful website at the University of Rochester Medical Center.
To register your trial:
1..Go to ClinicalTrials.gov Registration and complete the login fields, putting ‘UMDNJ' without quotes in the Organization field and the user name and password assigned to your department.
2. Note that the ClinicalTrials.gov-required fields are marked with a red asterisk (*) and the FDA-required fields are marked with a green FDAAA. Taken together, these data elements represent the requirements for an adequate registration. If you do not complete these fields, your trial may not be considered "fully registered." Note also that each field is labeled and linked to a definition; however, several fields are potentially confusing and should be completed as follows:
- Organization's Unique Protocol ID: Use the IRB number.
- Sponsor: The database will default to "UMDNJ" (although the university actually may not be the trial's sponsor).
- Collaborators: Sponsorship can be clarified by entering the actual sponsor's name. For unsponsored research, either leave the field blank or enter "None.
- Record Verification Date: Enter the date on which you complete and submit the template. This date must be updated no less often than every six months to ensure information is current.
- Conditions: Use the MeSH controlled vocabulary (provided). 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 (provided). If you don't,
4. The IND 1571 and IND 1572 - FDA Investigational Drug Forms
An IND application must be filed with the FDA for any clinical research that proposes the use of an unapproved drug or when clinical studies propose to use an approved drug for an off-label indication or at alternative doses. As the investigator of a privately sponsored clinical trial you must sign the FDA 1572.
FDA form required to be completed by the SPONSOR: 1571
The FDA form 1571 is completed by the industry sponsor who takes responsibility for and initiates the clinical investigation. The sponsor is the person who takes responsibility for and initiates a clinical investigation. The sponsor may be a pharmaceutical company, a private or academic organization, or an individual. A Sponsor-Investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug is being administered or dispensed. For administrative reasons, only one individual should be designated as sponsor.
If a pharmaceutical company will be supplying the drug, but will not itself be submitting the IND, the company is not the sponsor.
FDA form required to be completed by the Investigator and sent to Sponsor 1572
Whenever a sponsor selects a new investigator to participate in a clinical investigation that is being conducted under an investigational new drug application (IND), the sponsor must obtain a completed and signed 1572 from the investigator before permitting the investigator to begin participation in the clinical investigation (21 CFR 312.53(c)). The Form 1572 is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation.
The most recent version of the 1572 is available online.
5. The IDE - Investigational Device Exemption
An investigational device exemption (IDE) allows a medical device to be studied in humans so that safety and effectiveness data can be collected. An IDE also is used when studying substantial modifications to or new intended uses for devices already on the market.
The IDE is submitted by the Sponsor to the FDA. The data collected under an IDE is use to support a Premarket Approval (PMA), for Class III (high risk devices) devices or 510(k) Premarket Notification for Class I (least risk) and Class II (medium risk) devices. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution.
For more information on the IDE, click here.
Western IRB (WIRB), an independent commercial IRB located in Olympia, WA, has been contracted to act as one of UMDNJ's IRBs to review, approve and monitor industry-sponsored human subjects research.
All submissions to WIRB must go through the UMDNJ Human Subjects Protection Program.
Criteria for submission of studies for review by WIRB:
- Study is industry-sponsored, that is, the industry sponsor has written the protocol, is funding the research, and will monitor the conduct of the study.
- The research will be conducted at a UMDNJ performance site. (Site is owned and operated by UMDNJ)
- The investigator(s) is (are) UMDNJ employees
- The investigator(s) is (are) in good standing with the UMDNJ Campus IRB (e.g., no compliance issues, no expired studies, etc.)
- All study personnel involved in human subjects research have completed the Collaborative Institutional Training Initiative (CITI) Basic Course.
The UMDNJ Clinical Research Organization is working to encourage patient recruitment and school recognition by providing faculty at NJDS, NJMS, RWJMS and SOM access to the CenterWatch.com patient searchable database. CenterWatch.com is a global source of news, directories and analysis for clinical trials professionals and patients.
Its clinical trials database is one of the largest and most comprehensive listings of industry- and government-sponsored clinical trials on the Internet, with approximately 12,000 active clinical trials seeking study volunteers, and receiving more than 115,000 visitors monthly to its clinical trial, research center and career opportunity listings online. Each school has a Research Center Profile on CenterWatch.com and faculty may submit without cost unlimited numbers of trial postings in search of interested patients. The submission form is found on the faculty portal, downloaded here, or available through Susan Glick.
Articles and Resources:
- Clinical Trials Recruitment and Enrollment: Attitudes, Barriers, and Motivating Factors: A Summary of Literature and Market Research Reports Held by NCI as of August 2004
- Factors influencing physician referrals of patients to clinical trials
8. Good Clinical Practice
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for,designing, conducting performing, monitoring, auditing, recording, analysis and reporting reporting trials that involve human subjects. GCP practices provide assurance that the data and reported results are credible and accurate; and the rights, integrity and confidentiality of the trial subjects are protected.
The International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. Training is for all individuals involved, including chief investigators, monitors, study coordinators, data managers, principal investigators, other investigators, study administrators, research nurses QA managers, project managers, pharmacists
Good Clinical Practice Guidelines can be found on the FDA website:
GCP training can be taken through CITI Collaborative Institutional Training Initiative. Additional information on GCP can be found on the webpages of the UMDNJ Office of Human Subjects Protection. The National Institute of Allergies and Infections Diseases (NIH NIAID) offers free an online training.
9. UMDNJ Clinical Trial Policy, Other Research Policies, Indirect Cost Rate.
All research policies, including clinical trial cost sharing, can be found on the UMDNJ web at the following link: http://www.umdnj.edu/oppmweb/university_policies/research/
The Indirect Cost Rate for human clinical studies is assessed at the flat rate of 30% of direct costs.
It is the policy of the University to charge industry sponsors for all direct and indirect costs incurred in the conduct of industry-supported clinical trials. All potential sponsors of clinical trial programs must be informed of this policy before beginning negotiation of research project budgets that will be included in the research contract.
To calculate indirect cost when the direct costs are known, add 30% of the direct costs. The sum of these two figures is the per-patient amount.
Example: If $1,000 is needed to cover per-patien direct costs, 30% ($300) should be added for indirect, bringing the total to $1,300 per patient.
10. Export Controls and Publication Restrictions
Freedom of Research Publication and Consequences of Publication Restrictions
The expectation and mission to publish results of research exempts such research, and the University, from U.S export controls and requirements. This exclusion from export controls applies while the information is being developed; it applies after the research is complete and before results are published; it applies even if the results are not published. If the research is fundamental and the results are ordinarily either published or shared broadly with other scientists, the research results are protected. Restriction of research publication rights may cause the University to lose exemptions from export controls.
As a researcher, you will likely, at one time or another, intersect with federal regulations that impose access, dissemination or participation restrictions on the transfer of items and information regulated for reasons of national security, foreign policy, anti-terrorism or non-proliferation. In these situations, researchers are dealing with the Export Control Regulations of the United States.
Export controls, when applicable, may require UMDNJ to receive authorization from the US Government in the form of an export license. An export license permits "controlled" tangible items or software to be sent outside of the US, or for controlled information or software code to be shared with foreign persons in the US ("deemed exports") or abroad. Most of the tangible items, information or software that UMDNJ ships or shares with its colleagues and research partners is not of a nature that would be restricted for these purposes, nor are they frequently destined for countries or individuals subject to US embargoes or sanctions. UMDNJ, however, is required to demonstrate its export control due diligence and to document its adherence to US export controls and trade sanctions laws.
Decision Trees for Export Controls: International Travel and Research
The following links are decision trees created by other Universities for their researchers to guide them in export control decision-making and to determine if items, information or software would be restricted from transfer or require other action to transfer.
These links can be used as a general guide. For specific question, contact your Office of Sponsored Research.
11. Quality Improvement: Self-Assessment Guide to Study Management
12. UMDNJ CRO Discussion Board
The CRO hosts the UMDNJ Clinical Research Discussion Board. This listserv is a University-wide forum for faculty and staff who initiate, support, and manage clinical research. Receive timely notices and updates, answers to questions, and communicate with others throughout the University conducting clinical research.
If you would like to join, contact Susan Glick.
13. CenterWatch.com Profiles and Submitting Clinical Trial Opportunities to CenterWatch.com Online Database
The annual CenterWatch.com membership provided to you by the UMDNJ CRO provides the posting of 1) a profile of your school on the website and 2) unlimited clinical trials into a trials database searchable by individuals looking to participate in a clinical trial. Centerwatch.com is one of the premier sites for clinical trials for both sponsors and potential patients use it. Sponsors use it to identify new sites for their studies. Individuals searching for a clinical trial complete a simple registration form on the site indicating the conditions they are interested in (up to 24) and the state in which they are seeking trials. This service is free to individuals.
Research Center Profile
As part of your annual membership to CenterWatch.com, your school will have a profile posted at http://www.centerwatch.com/news-resources/research-centers/profile-locations.aspx
The image below is a “printscreen” image to give you an example of what you will find for UMDNJ.
Posting Trials to the Searchable Clinical Trials Database
The second service you will receive is free posting of unlimited clinical trials into the patient searchable database. In order for you or your investigators to submit a clinical trial for public posting, open the following link:
The link will direct you to the web-based form to submit your clinical trial to CenterWatch.com. The form can also be found in my.umdnj.edu with the faculty portal. Faculty may locate the form in the Welcome Tab, Faculty Tool Box and under the Research Tab, under Clinical Trials. Finally, the posting form and instructions will be soon be posted on the CRO website, under Investigator Resources.
The posting may be submitted in any text/letter based language. The postings may reference any ongoing or new study being conducted in all disease areas. CenterWatch.com will post this trial to their searchable clinical trials database with 1 or 2 days. It is important to remember that you clinical trial postings compete within the database; clinical trial benefits should be included in the posting. Sample postings can be found at the following link:
Below is a partial screen shot of what the electronic posting-form looks like.
To simplify working with CenterWatch.com, Susan Glick has agreed to be a liaison with the site. If you have questions, please contact her at email@example.com. She will receive an email confirmation when a trial has been successfully posted by CenterWatch.com and forward the email to the appropriate individual at your school.
In addition, CenterWatch.com has agreed to periodically provide a download of registered trials to Susan. She will forward the information to the appropriate individual at your school. Using this downloaded data, your school should to identify which trials are closed and forward such information to Susan. Closed trials will be reported to CenterWatch.com for removal from the database. If you have questions, please contact Susan at firstname.lastname@example.org.
14. Online Training Resources
- Clinical Research Training and Career Development - Open Access Lectures and Seminars from Institute of Translation Health Sciences (ITHS)
15. Funding Resources
16. Conflict of Financial Interest
The U.S. Department of Health and Human Services (HHS) issued a final rule in August 2011 in the Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf) that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).After considering all public comments, and consistent with the proposals articulated in the NPRM, HHS developed the final rule, which includes the following major changes to the 1995 regulations. The changes below are effective August 24, 2012.
Significant Financial Interests (SFI) threshold
De minimis threshold of $10,000 for disclosure generally applied to payments or equity interests
De minimis threshold of $5,000 for disclosure generally applies to payments for services and/or equity interests. Includes any equity interest in non-publicly traded entities.
Which SFIs need to be disclosed (once the threshold is met)
Only those SFI the Investigator deems related to the PHS-funded research.
All SFI related to the Investigator’s institutional responsibilities.
Travel reimbursements and sponsored travel
Travel reimbursement was not mentioned in the regulations but was not excluded from the SFI definition.
Disclose the occurrence of any reimbursed travel or sponsored travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration). NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution will determine if any travel requires further investigation, including determination or disclosure of the monetary value.
REFERENCE TO FULL CHANGES
Any financial or other personal interest must be reported to the appropriate school Research Dean for review by the Conflict of Interest Committee (COIC). COIC is a University-wide committee whose role is to review disclosures of significant interests and determine if these constitute a conflict of interest, and, if so, to decide how such conflicts will be managed, reduced or eliminated.
- Investigator Financial & Other Personal Interests Disclosure Form
- Investigator Conflict of Interest – University Policy
- Faculty Honoraria