Accepted Protocol Submission (APS)

Once the final protocol is acceptable, the Investigator must complete an Accepted Protocol Submission (APS) via the TAP website iir-tap.com

A completed IRS-W9 form will be required for funding payments. The TAP website, as well as the MERL, is a resource to advise the investigator of all required documents.

Funding negotiations, if required, are conducted with the TAP IIR staff and are finalized prior to TAP IIR staff requesting a Study Agreement from the TAP Legal Department.

Documentation required for submission of an approved protocol to TAP:

Study Agreement

Once TAP IIR staff receives the online submission notification of the Accepted Protocol Submission and accompanying documentation via the TAP website iir-tap.com, they will be reviewed by TAP's IIR staff prior to routing to TAP's Legal Department.

TAP's Legal Department will prepare an initial draft of the Study Agreement for an initial review by the Investigator's or Institution's Legal Department. The Study Agreement may be between TAP and the investigator, or between TAP and the institution with which the investigator is affiliated. If the Study Agreement is between TAP and an institution, the Investigator, in most instances, will be asked to agree to and sign acknowledgement of the Study Agreement as well.

In general, the Study Agreement sets forth the obligations of the Institution, Investigator and TAP in relation to the study. The specific contents of the Study Agreement will vary depending upon the particular study. However, most Study Agreements contain language pertaining to the following topics:

Once TAP's Legal Department has prepared a draft of the Study Agreement, it is forwarded to the Investigator and/or the Investigator's institution for review. Once all parties agree on a final version of the Study Agreement, TAP's Legal Department generates two hard copies and submits them to TAP's Contract Management Group (CMG). CMG routes the final versions of the Study Agreement internally for TAP signature first and then sends the partially-executed copies to the Investigator and/or the Investigator's Institution for signature. Once the Institution and/or the Investigator sign the Study Agreement, one fully-executed copy must be returned to TAP.

 

Regulations

TAP requires investigators to comply with all applicable federal and state regulations and local ordinances for clinical and/or non-clinical research. An investigator may be required (according to federal regulations) to file an Investigator IND with respect to his or her particular study.

For those studies that require IRB approval and/or an Investigator IND, the Investigator enters the date of IRB approval and/or the date of the FDA's acknowledgement of the IND into the TAP IIR database system.

There are FDA regulatory requirements for investigators and sponsors related to the use of an investigational new drug in a clinical investigation. Generally, these requirements may be found at:

 

Generation of the IND :

Not all IIR protocols require an IND. More information on filing an IND may be found at:

http://www.fda.gov/cder/forms/1571-1572-help.html

http://www.fda.gov/cder/about/smallbiz/faq/htm;

Additional information regarding the responsibilities of a Sponsor, an Investigator, IRB and Informed Consent requirements, and other regulatory requirements for clinical research may be found at:

http://www.fda.gov/oc/gcp/default.html

http://www.gpoaccess.gov/cfr/index.html

http://www.fda.gov/oc/gcp/regulations.html

http://www.fda.gov/cder/guidance/959fnl.pdf

 

Clinical Registry

Certain studies are subject to the Food and Drug Administration Amendments Act of 2007 (US Public Law 110-85, HR 3580). According to the Act, certain controlled clinical trials of drugs, biologics or devices (excluding Phase I trials) must be registered, by the trial's sponsor, on clinicaltrials.gov and their results posted on the clinicaltrials.gov data bank. Additional details can be obtained within the Act.

To comply with federal law and ensure the ability to publish study results, investigators must register clinical trial protocol information onto clinicaltrials.gov website before enrolling the first patient.

Section 113 of the FDA Modernization Act of 1997 requires Investigators to register protocol information related to clinical trials for serious or life-threatening diseases and conditions on the ClinicalTrials.gov website. The link below may be helpful to Investigators in providing additional information on this requirement: (press the CONTROL key while clicking on the link)

http://prsinfo.clinicaltrials.gov/fdama-113.html .

The International Committee of Medical Journal Editors (ICMJE) issued editorials stating that the ICMJE will consider a trial for publication only if the trial has been registered before the enrollment of the first patient. To view the ICMJE editorials related to this topic, press the CONTROL key while clicking on the following link:

http://prsinfo.clinicaltrials.gov/icmje.html .

Investigators who are new to the ClinicalTrials.gov website must go to http://prsinfo.clinicaltrials.gov/ to set up an account and obtain a password prior to registering any study information.

To view a list of the data sets that must be registered on ClinicalTrials.gov, press the CONTROL key while clicking on this link:

Trial Registration Requirements

All information registered on ClinicalTrials.gov website must be kept current at all times. Investigators are responsible for ensuring that all entries on the site are updated when any changes are made to the study and are reviewed at a minimum of every 6 months.

 

Clinical Supplies

Investigators may request that TAP provides drug for use in conducting an IIR study.

Requests for commercial TAP products require minimal lead time (5 business days),

TAP's IIR staff will work with the investigator to supply the requested drug.

The packaging vendor includes a packing list with each shipment. The bottom half of this packing list serves as an “Acknowledgement of Receipt” which is completed and the original maintained by the investigative site. A copy must be faxed to TAP's IIR Staff at 1-847- 582 -2403 by the Investigator.

It is the responsibility of the Investigator to maintain the clinical supplies in the appropriate conditions, track receipt, usage, and destruction and/or return. Details on where to return clinical supplies is provided in the Study Agreement.

 

Subject Safety

The Study Agreement sets forth the obligations of the Institution, Investigator and TAP in relation to serious adverse event reporting for the study.

In general, the Study Agreement will provide that if the administration of the drug occurs under the Institution and/or Investigator's Investigational New Drug Application (IND), pursuant to the Code of Federal Regulations Title 21, Section 312.32(c). The Institution and/or Investigator will assume responsibility for adverse event reporting. If the administration of the drug does not occur under an IND , pursuant to the Code of Federal Regulations Title 21, Section 314.80, the drug's manufacturer will assume the responsibility of reporting adverse events.

Whether the adverse event is considered a clinical or post-marketing event, TAP requires that all information be communicated to TAP's Pharmacovigilance Department at pharmacovigilance@tap.com , Fax Number 1-847-582-5605 or Phone Number 1-800-622-2011 option 2.

Additional information on Reporting to FDA may be found at:

http://www.fda.gov/medwatch/REPORT/mfg.htm

 

Publications

Disclosure of research results by the Investigator is an expectation of TAP. Research results can be submitted for publication as abstracts at scientific congresses or as manuscripts in peer-reviewed journals.

Each congress and journal has individual requirements (e.g., types of research papers accepted, preferred format, maximum word count, etc.). Investigators should consult the requirements that can be found under “Instructions for Authors” or “Call for Abstracts” links on the respective journal or congress website.

Many journals including JAMA, The New England Journal of Medicine, and The Lancet adhere to the International Committee of Medical Journal Editor's (ICMJE) requirements respecting manuscript format and publication ethics. TAP requires the Investigator agrees to comply with the current version of The Uniform Requirements for Manuscripts Submitted to Biomedical Journals established by ICMJE as well as the other generally recognized standards concerning publication and authorship.

The ICMJE issues updates to its requirements on a regular basis. Investigators may view the current version of ICMJE requirements online at www.icmje.org .

The Investigator must provide a copy of an abstract or presentation and a manuscript to TAP for courtesy review at least 30 days prior to submitting any work for publication or presentation. A final report may also be requested. The Investigator is not obligated to accept or act on any of the comments that TAP provides.



 
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