Q: Do CDAs need to be routed?
A: No, please do not route CDA’s. Send them to the firstname.lastname@example.org mailbox.
Q: What information is needed when submitting a CDA to the Office of Clinical Research mailbox?
A: Please send the editable word version of the CDA template from the industry sponsor if provided, the sponsors contact information including name, email address and phone number, please make sure to include the “purpose” of the CDA (typically a protocol # and/or protocol name), the investigator and the IU department contact’s information.
Q: Do I need a one-way CDA template?
A: If you are receiving information from the industry sponsor only and not providing any information to the industry sponsor then you will need a one way CDA.
Q: Do I need a mutual CDA template?
A: If you are receiving information from the industry sponsor and you are providing information to the industry sponsor regarding the proposed purpose the you will need a mutual CDA.
Q: Does IU have a one-way CDA template and/or a mutual CDA template to provide to industry sponsors if the sponsor did not provide one initially?
A: Yes, We have both CDA templates which can be found on the OCR website.
Q: Where can I send questions to regarding CDA’s?
A: Please send your CDA questions to the email@example.com mailbox.
Q: How will I know when my CDA is being worked on by a contract officer?
A: You will receive an email once your CDA has been assigned with your contract officer’s contact information and you will be cc’d on all emails unless you request otherwise.
Q: Where can I send general questions about contracts?
Q: Is there a phone number I can call to get in contact with the OCR?
A: (317) 278-2546
Q: What is the OCR address:
A: Indiana University
Attn: Office of Clinical Research
410 W. 10th Street
Indianapolis, IN 46202
Q: My industry sponsor is requesting a W-9 form, where can I obtain a copy?
A: Please send your inquiry to firstname.lastname@example.org and we can provide you with the W-9 form
Q: Does the CRO negotiate material transfer agreements?
A: No. The Grants Office in the Office of Research Administration negotiates material transfer agreements. Please contact them at (317) 274-7925 or view their website.
Q: What types of contracts does the CRO negotiate?
A: The IU-CTO negotiates industry sponsored agreements: clinical trials agreements, confidentiality disclosure agreements, master agreements, and subcontracts for clinical trial agreements.
Q: What is the current indirect costs for CRO clinical trials?
Q: What is the legal name for Indiana University?
A: Trustees of Indiana University
Q: Do Indiana University investigators sign CRO contracts as a party to the agreement?
A: No. As employees of Indiana University conducting research within his/her role as an employee, investigators do not sign CRO contracts as a party.
Q: If Indiana University principal investigators do not sign CRO contracts as parties, what do they sign as?
A: Indiana University principal investigators sign as employees of Indiana University; therefore, they sign as “Read and Acknowledged”.
Q: What does CTA refer to:
A: Clinical trial agreement
Q: What does CDA refer to:
A: Confidential disclosure agreement
Q: What are other names for clinical trial agreement?
A: CTAs can be called clinical study agreements, research study agreements, etc.
Q: What are other names for confidential disclosure agreements?
A: CDAs can be called confidential non-disclosure agreements, mutual disclosure agreement, bilateral confidential agreements, etc.
Q: If the Indiana University principal investigator for a study is not available to sign a negotiated CRO contract, can someone else in his/her department sign on their behalf?
A: No. The Indiana University principal investigator must sign the contract.
Q: Do you have a template that I can send out to a sponsor?
A: Yes. Any changes to these contracts must be reviewed by the CRO. To find the templates, please click Contract Templates.
Q: To whom should payment checks be made and what is the address for payments
The Trustees of Indiana University
P.O. BOX 78000
Detroit, MI 48278-0945
Reference: Protocol #/PI Name
Tax ID: 35-6001673
Q: Does your office handle clinical trial accounts?
A: No. For all account information, please contact Cindy Green in the Office of Research Administration.
Q: What if I need to open an account before the contract is finished?
A: For underwrites, please contact Cindy Green in the Office of Research Administration. Accounts may only be underwritten for non-patient related purposes (E.g., ordering supplies, etc.)
Q: What needs to be routed?
A: Any contract that requires the signature of Indiana University, with the exception of CDA’s, needs to be routed.
Q: Why can’t I just sign the contract?
A: Only certain individuals have the legal authority to bind Indiana University to obligations with a third party. If the contract is not signed by one of these individuals, the contract will have no binding effect.
Q: How can I check on the status of my contract?
A: Questions regarding contract status can be sent to CTO@IU.EDU or you may call 317-274-CLIN
Q: How is an industry-sponsored clinical trial and an investigator-initiated clinical trial similar? How are they different?
A: Below is a chart outlining some similarities and differences
||Principal Investigator (PI) -Initiated
||a) Protocol authored by a UCSD Investigator within the course and scope of his/her University employment; or
b) A UCSD Investigator within the course and scope of his/her University employment jointly with an employee of another entity (e.g. an employee of another non-profit institution or/and employee of the company funding the study)
|a) Protocol is authored by a non-UC employee (i.e. the company’s employee or an employee of an outside university or institution), or
b) A University investigator under a personal consulting agreement and without use of University facilities in accordance with UC Policies
||27% Clinical Trial IDC (assessed on all costs)
||27% Clinical Trial IDC (assessed on all costs). See OCTA website
||Although the actual payment schedule is subject to negotiation with the company, the Principal Investigator and departmental administrators should develop a suggested payment schedule that is based upon the spending pattern anticipated for the study. The initial payment should include non-refundable start-up costs, as appropriate. Subsequent payments may be due quarterly, or based on subject enrollment. The University may not underwrite expenses for the company, and reimbursement should remain current with expenditures throughout the life of the study.
||Although the actual payment schedule is subject to negotiation with the sponsor, the Principal Investigator and departmental administrators should develop a suggested payment schedule that is based upon the spending pattern anticipated for the study. The initial payment should include non-refundable start-up costs as appropriate. Subsequent payments may be due quarterly, or based on subject enrollment. The University should not underwrite expenses for the sponsor, and reimbursement should remain current with expenditures throughout the life of the study.
||In general, Investigator-Initiated Clinical Trials are either Phase I or Phase II Trials and may be multi-site studies.
||In general, Industry-Initiated Clinical Trials may include Phase I through IV and are usually multi-site studies.
|Investigational New Drug (IND)/ Investigation Device Exemption (IDE)
||Submitted to FDA by faculty
||Submitted to FDA by Sponsor
||a) The University retains the right to publish the results of the Clinical Trial consistent with University policy.
b) The Principal Investigator is responsible for registering the trial for publication.
|a) The University retains the right to publish the results of the Clinical Trial consistent with University policy.
b) The Principal Investigator coordinates with the industry sponsor to determine who will assume responsibility for registering the trial so the results may be published.
||The University retains all rights to inventions developed under the Study. If the funding source for the Clinical Trial is a for-profit entity, the entity will be granted the first right to negotiate for a license to commercialize such invention. If funding source is a non-profit entity, the non-profit entity will be granted certain non-commercial rights to the invention.
||In general, the industry sponsor will own any patentable inventions developed in the direct performance of the protocol.
||a) The company receives a summary report of the results of the trial, and may receive case report forms, as appropriate. The report may be used by the company for any purpose, subject to the University’s intellectual property and publication rights.
b) Since the company funding the trial is not the regulatory “sponsor” as the term is defined in the Code of Federal Regulations 21CFR50, the company may not access medical records or other patient identifying information unless a revised authorization specific to the study, and which complies with CMIA requirements is obtained from the subject.
|a) The industry sponsor owns the completed case report forms and compilation of data expressed therein that is developed under the trial, and any deliverables required under the protocol. However, the University retains the right to use the case report forms and results for publication, educational and research purposes.
b) The industry sponsor may receive and use de-identified clinical trial specimens (blood samples, x-rays, etc.).
c) The University retains ownership and unrestricted use of original “raw” data including clinical trial specimens. The industry sponsor may have access to, raw data for FDA inspection/monitoring.
d) The industry sponsor may access, but not copy, subjects’ medical records containing individual identifiable patient information for the limited purpose of auditing data quality and monitoring the study as required under FDA regulations. The disclosure is allowed under HIPAA, however, such disclosure is not allowed under CMIA without subject’s authorization.
||Except for injury attributable to the manufacture of the study drug, the University assumes responsibility for any injury directly resulting from the subject’s participation. The University will provide medical treatment for any such injuries. It is unacceptable to require billing of third party insurance companies in lieu of recovery of such costs. Neither is it appropriate to restrict participation of subjects based on medical insurance coverage status or the subject’s ability to pay.
||The industry sponsor is responsible for any injury directly resulting from a subject’s participation in the trial, or injuries resulting from the study drug, or the placebo, or protocol procedures. The industry sponsor will reimburse the University for the costs of medical treatment for such injuries. It is unacceptable to require billing of third party insurance companies in lieu of recovery of such costs. Neither is it appropriate to restrict participation of subjects based on medical insurance coverage status or the subject’s ability to pay.
||a) Request for Extramural Support (RES Form)
b) 700-U Conflict of Interest Form completed for the PI and Co-PI
c) Statement of Work (i.e. protocol)
d) Budget 27% (Total Direct Costs) IDC. The budget includes any sub sites participating in the study.
|a) Clinical Trial Agreement Request
b) 700-U Conflict of Interest Form completed for the PI and Co-PI
c) Budget 27% (Total Direct Costs) IDC. The budget includes any sub sites participating in the study.
d) HIPAA Authorization
e) Application for Institutional Research Bulk Account
f) Clinical Trial Agreement Request Addendum
|Authorized Administrative Office
||Investigator-Initiated Clinical Trials are processed and negotiated by the IU-CTO
||Industry-Initiated Clinical trials are processed and negotiated by the IU-CTO
||Account set-up via ORA
||Account set-up via ORA