PCF Clinical Attachment Instructions

Proposals for all sponsored activities (including research, instruction, service, clinical research, and clinical trials/drug/device studies) must be submitted to the Office of Sponsored Programs Administration (SPA), the Office of Industry Engagement (OIE) or Clinical Contracts Division (CCD) as appropriate in accordance with these instructions for review and approval prior to submission to the sponsor.

When either question 5a, b, or c on the PCF is answered yes, the PCF Clinical Attachment for Proposals form is needed. The PCF Clinical Attachment for Proposals form should be attached to the PCF and accompanying documents.

OFFICE SUBMISSION GUIDELINES:

Submit to
Clinical Contracts Division:

  • Clinical projects funded directly by industry or private nonprofit organizations, including projects with flow-through funding when ULRF’s direct payer is nonfederal, even if the primary sponsor is federal

Submit to
Office of Industry Engagement
:

  • Projects funded by industry and for-profit organizations
  • Projects involving small businesses or for-profit entities with governmental flow-through (e.g., federal SBIR/STTR programs, or certain KSTC programs) in which a business applies for and receives an award, and the business – not the governmental funding agency – contracts with the university)

Submit to
Sponsored Programs Administration:

  • Projects funded by governmental agencies or private nonprofit organizations
  • Clinical projects of any type funded directly by the federal government

Question 5 on the PCF:

  1. Is this proposal for a CLINICAL TRIAL/DEVICE/DRUG STUDY? __ No __ Yes
  2. Will this proposal involve any affiliated hospital site (ULH, NHC, JHSMH, OMHS, VAMC)? __ No __ Yes
  3. Will this proposal involve specimens, tissues or personally identifiable (not de-identified as defined by HIPAA) data/information (human materials) __ No __ Yes

Note for Public Health Service (PHS) Funding: New federal Conflict of Interest regulations include a requirement that disclosures be made at the time of proposal for PHS. Each named member of a project team must have an updated Attestation and Disclosure Form (ADF) on file at time of proposal in order to be included on the submission. If there are positions (technicians, post docs, etc.) who will be hired if the award is received, those can be noted TBD. However, if an individual is named, he/she must have a current Attestation and Disclosure Form (ADF).

1. Tracking Number. If you have a tracking number assigned to the proposal, enter it here. If not, this will be added by SPA, OIE or CCD upon entry of the proposal into PeopleSoft.

2. Date. Enter the date of submission of form to SPA, OIE or CCD.

PRIMARY CONTACTS FOR PROJECT

3. Clinical Contact. Identify the individual who is the clinical contact on the study, such as the clinical coordinator.

    Name of the contact
    Contact’s UofL employee ID number
    Contact’s title
    Contact’s university email address
    Contact’s university telephone and fax numbers

4. Regulatory Contact. Identify the individual who is the regulatory contact on the study. Simply check the box if this individual is also the clinical contact.

    a. Name of the contact
    b. Contact’s UofL employee ID number
    c. Contact’s university email address
    d. Contact’s university telephone and fax numbers

PROJECT CHARACTERISTICS

5. Under FDA “Compassionate Use.” Check whether or not the study falls under the FDA Treatment IND guidelines for “compassionate use.” This term is used to describe a method of providing experimental therapeutics prior to final FDA approval for use in humans. This process typically is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy. Provide a copy of the FDA clearance letter, if applicable.

Source: Medicine Net.com Definition of medical terms
http://www.medterms.com/script/main/art.asp?articlekey=30711

The following description of “compassionate use” will assist you in answering “yes” or “no.”

A formal compassionate use program is a mechanism for getting an unapproved but promising new treatment to patients who would otherwise be unable to receive it. Compassionate use programs are for people who have a life-threatening illness with "no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population" (in the words of the FDA regulations).

Formal compassionate use is a bit like a clinical trial in that you will still have to meet specific requirements such as the type and stage of disease, and usually you must be treated by doctors who participated in the clinical trials for the drug, but compared to trials, the requirements are somewhat relaxed. If you qualify for an open clinical trial of the treatment, obtaining it through compassionate use is not an option.

According to the FDA regulations, compassionate use programs are normally for drugs which are in phase III or have completed accrual to their trials (it takes significant time to allow the data to mature, compile it, and get it reviewed by FDA–often several years), but the regulations do say compassionate use might be possible for some drugs which are only in phase II testing. I presume there would still have to be applicable promising results–such as spectacular results from an ongoing phase II trial. You won't find compassionate use programs for drugs which are in the very early stages of testing. If you just heard about the latest cancer cure for mice on the nightly news, you can be sure there will not be a compassionate use program. There have to be results in people with your type of cancer.

Although the FDA has to approve compassionate use programs, they normally do so without fuss. Whether there is a compassionate use program largely depends on whether the drug company has decided to have one. The decision depends on many factors including the cost which can easily run into the millions and whether there is an adequate supply of the drug (which is often an issue).

Source: Off-Protocol: Getting New Treatments Outside a Clinical Trial found at http://cancerguide.org/offprotocol.html

6. Drug/Device FDA-Approved for Indication

  1. Check whether or not the subject drug or device has been approved by the FDA for the subject indication. Check the box for not applicable if no drug or device is involved in the study. For information regarding investigational new drugs, see Center for Drug Evaluation and Research (CDER) at http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm. For investigational new devices, FDA Device Advice: Comprehensive Regulatory Assistance at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UCM2005299.htm.
  2. Enter the name of the drug or device, if applicable.

7. FDA Phase. For most industry-sponsored clinical trials, the sponsor will have identified the FDA phase of the study. Note that the FDA phase may differ from the NIH phase. Please mark both if applicable. Refer to http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070567.pdf for additional information.

  1. Phase I Trials. Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

    NIH I Trials. The phase 1 study is used to learn the "maximum tolerated dose" of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects.

  2. FDA II Trials. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.

    Phase II trials are sometimes divided into phase IIa pilot trials and phase IIb well controlled trials.

    NIH II Trials.

    The phase 2 study involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study.

  3. Phase III Trials. Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.

    Phase III trials are sometimes divided into phase IIIa trials, conducted before regulatory submission, and phase IIIb trials, conducted after regulatory submission but before approval.

    NIH III Trials. The phase 3 study compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition. Determining the true benefit of a drug in a clinical trial is difficult.

  4. Phase IV Trials. Post-marketing studies to delineate additional information including the drug's risks, benefits and optimal use or new indications for the drug.

     

  5. Not applicable

Source: ClinicalTrials.gov Glossary, http://clinicaltrials.gov/ct/info/glossary

8. Funding Source. Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.

  1. Industry
  2. Government
  3. Cooperative group. Cooperative groups are informal and formal networks or groups of individuals or organizations that work together on clinical studies. They may work on common protocols at multiple entities. Examples of cooperative groups are SWOG–SouthWest Oncology Group, PPRU–Pediatric Pharmacology Research Unit network.
  4. Foundation
  5. Not funded
  6. UofL. Internally funded by UofL.
  7. ULH/NHC/JHSMH/OMHS. Funded by University of Louisville Hospital (ULH), Norton Healthcare (NHC), Jewish Hospital & Saint Mary’s Healthcare (JHSMH), or Owensboro Medical Health System (OMHS).
  8. Other. If checked, explain in the space provided.

9. Multicenter Study. The National Cancer Institute defines a multicenter study as a clinical trial that is carried out at more than one medical institution. Check whether or not the study will be conducted at institutions or organizations other than the University of Louisville. Having a clinical trial agreement with ULRF which has the principal investigator seeing subjects at Norton Healthcare, Jewish Hospital & St. Mary’s HealthCare, University of Louisville Hospital, Owensboro Medical Health System and/or Veterans Affairs Medical Center does not qualify as multicenter.

10. Author of Protocol. Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.

  1. Investigator
  2. Sponsor
  3. Cooperative group. See 8c above for explanation.
  4. Other. If checked, explain in the space provided.

11. Initiator of Study. Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.

  1. Investigator
  2. Sponsor
  3. Cooperative group. See 8c above for explanation.
  4. Other. If checked, explain in the space provided.

12. Type of Study. Check all the categories that apply. In most situations, only one box will be checked; however, it is possible that more than one item is applicable.

  1. Drug study
  2. Device study (Provide the FDA clearance letter, if applicable.)

      i. Premarket Application (PMA)

      ii. Premarket Notification 510(k)

  3. Chart review
  4. Observational study
  5. Specimen study
  6. Registry of data or information
  7. Repository of physical tissue or biological samples
  8. Other. If checked, explain in the space provided.

13. Transfer of Biological/Chemical Materials. Indicate if human and/or non-human materials or other biological/chemical materials are being received by the University from another entity or if we are sending such from the University to another entity.

SITE FACILITIES AND RESOURCES

14. Study Sites. Indicate the entities at which subjects will be seen, facilities will be used or resources will be used or provided. While you do not want to check locations you won’t use, you should include those with a reasonable likelihood of being used or where subjects for the study will be enrolled. Except for the UofL facilities (first site), these entities are considered “third parties” with regard to contracting, which means additional contractual arrangements and/or approvals must be made to bring them into the project. Remember that approval by each facility/site is required in addition to university approval and contract execution.

For each facility/site to be used, check all applicable areas of involvement:

      i. Places—Facility/Department Use. Project (or a portion of it) will be performed within the facility. Specific departments within the facility will be engaged in providing services for the project, performed by either UofL personnel or facility personnel. Check each applicable department. The options are blood bank, cath lab, laboratory, nutrition, pathology, pharmacy, physical therapy, radiology, respiratory therapy and other (please identify in the space provided). If the facility is providing SPACE only, please select “Other” and so state.

      ii. Information—Confidential Information. Facility personnel will have access to sponsor’s confidential information, such as the protocol.

      iii. People—Perform Research Services. Facility personnel will perform research services pertaining to the project. Please indicate for RESEARCH services only (as opposed to conventional care or in addition to conventional care). Contact the specific facilities involved for their pricing on research.

      iv. Items—Equipment/Drug/Device. Any drug, device, equipment, compounds, software or other resources—which have been provided or loaned by the sponsor—will be used or housed in the facility. Note that provision of any such resource in lieu of funding means the project is a sponsored activity and subject to university review and authorization, just as a funded project would be.

  1. UofL Facilities. Provide building names and room numbers.

    Ambulatory Care Building (ACB), other space owned or leased by UofL at Health Sciences Center (HSC), Belknap Campus, Shelby Campus, UofL Clinics, and Cardinal Research Cluster (CRC)

  2. University of Louisville Hospital (ULH) - part of KentuckyOneHealth - CIRI

    Space in or services performed within the UofL Health Care Outpatient Center (HCOC), or any other ULH facility (enter the name and address of the facility in the space provided)

  3. Jewish Hospital & St. Mary’s Healthcare - part of KentuckyOneHealth - CIRI

    Frazier Rehab Institute, Jewish Hospital, Jewish Hospital Medical Center East, Jewish Hospital Medical Center Northeast, Jewish Hospital Medical Center South, Jewish Hospital Medical Center Southwest, Jewish Hospital Outpatient Center, Jewish Hospital Rudd Heart and Lung Center, Jewish Hospital Shelbyville, Our Lady of Peace Hospital, Saints Mary & Elizabeth Hospital, St. Mary’s Surgery Center, Health Resource Center, Southern Indiana Rehab Hospital, Taylor Regional Hospital, VNA Nazareth Home Care, Jewish Hospital Health Center—Meade County, Jewish Hospital Hand Care Center, or any other JHSMH facility (enter the name and address of the facility in the space provided)

  4. Norton Healthcare Facilities

    Norton Hospital, Norton Children's Hospital, Norton Audubon Hospital, Norton Brownsboro Hospital, Norton Women's and Children's Hospital—St. Matthews, Norton Children's Medical Center—Brownsboro, Norton Medical Plaza—Brownsboro, space leased by UofL in a Norton Healthcare facility, Norton Physician Practices, or any other NHC facility (enter the name and address of the facility in the space provided)

  5. Owensboro Medical Health System. Enter the name and address of the facility in the space provided.
  6. Veterans Affairs Medical Center. Note that projects utilizing VA facilities or resources will require a separate submission to the VA. Enter the name and address of the facility in the space provided.
  7. Private Practice or Professional Service Corporation (PSC). This includes those located within the UofL Health Care Outpatient Center (HCOC). Enter the name and address of the group in the space provided.
  8. Other. Enter the name, contact information and address of the site in the space provided.

If you have any question about the items on the PCF Clinical Attachment for Proposals, please contact the appropriate office: Sponsored Programs Administration or Clinical Contracts Division.