Resources for the RBHS Investigator

  1. Submitting Agreement/Document to Legal Management
  2. Do you need help to start a study?
  3. ClinicalTrials.Gov Submission- What to know
  4. The IND 1571 and IND 1572 - FDA Investigational Drug Forms
  5. The IDE- Investigational Device exemption
  6. IRB Submission: WIRB
  7. Recruitment and CenterWatch.com
  8. Good Clinical Practice
  9. RBHS Clinical Trials Policy, Other Research Policies and Indirect Cost Rate
  10. Export Controls and Research Publication
  11. Quality Improvement - Self-Assessment Guide to Study Management
  12. The Rutgers CRO Discussion Board
  13. Submitting Clinical Trial Opportunities to CenterWatch.com Online Database
  14. Online Training Resources
  15. Funding Resources
  16. 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:

Submit CDA, CTA or other agreement to Legal Management.

All documents must be submitted in Word format and only RBHS 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 RBHS 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.

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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:

  1. Protocol
  2. Budget
  3. Contract
  4. RBHS Forms

The FDA has an excellent section specifically for understanding clinical trials: Running Clinical Trials: FDA Requirements, Guidelines and Resources - A Comprehensive Review.

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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."

To learn how to register your research please view the RU IRB ClinicalTrials.gov Page.

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.
  • There may be financial penalties for not properly registering at ClinicalTrials.gov.

 


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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.

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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.

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6. WIRB

 

 

Western IRB (WIRB), an independent commercial IRB located in Olympia, WA, has been contracted to act as one of RBHS' IRBs to review, approve and monitor industry-sponsored human subjects research.

 

All submissions to WIRB must go through the RBHS 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 RBHS performance site. (Site is owned and operated by RBHS)
  • The investigator(s) is (are) RBHS employees
  • The investigator(s) is (are) in good standing with the RBHS 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.

Helpful Links:

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7. Recruitment

 

CenterWatch.com
CenterWatch.com is a global source of news, directories and analysis for clinical trials professionals and patients. The Rutgers Clinical Research Organization is working to encourage patient recruitment and school recognition by providing faculty at RSDM, NJMS, and RWJMS access to the CenterWatch.com patient searchable database.

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 the patient-searchable Centerwatch.com database of available trials.

Articles and Resources:

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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 RBHS Office of Human Subjects Protection.  The National Institute of Allergies and Infections Diseases (NIH NIAID) offers free an online training.

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9. Clinical Trial Policy, Other Research Policies, Indirect Cost Rate.

 

All research policies, including clinical trial cost sharing, can be found on the web at the Rutgers University Policy Library.

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.

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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.

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 RBHS 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 RBHS 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. RBHS, however, is required to demonstrate its export control due diligence and to document its adherence to US export controls and trade sanctions laws.

Export Controls at Rutgers, The State University of New Jersey

Guidelines for Export Control at Rutgers can be found here. Rutgers Export Compliance Officer (RECO), Robert Phillips, is available to meet with individuals or groups to provide assistance, training or explain the regulations as they may be applicable to the work being done. He can be reached at 848-932-4522, or via email at robert.phillips@rutgers.edu.

 

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.

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11.  Quality Improvement: Self-Assessment Guide to Study Management

 

RHBS Self Assessment tool to support study management and record keeping.

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12.  Rutgers CRO Discussion Board

 

The CRO hosts the Rutgers 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 Diane Ambrose.

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13.   CenterWatch.com Profiles

         Submitting Clinical Trial Opportunities to

         CenterWatch.com Online Database

 

The annual CenterWatch.com membership provided to you by the Rutgers 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 RBHS.

 

screenprint

 

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.

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.

 

screenprint

 

 

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14. Online Training Resources

 

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15. Funding Resources

 

 

Pivot - Community of Science

The Foundation Center

Fundsnet Online

ScanGrants

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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.

 

 

Topic

Prior Regulation

New Regulation

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

 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-109.html

FAQs

 

http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

 

 

University Forms

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.

 

 

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