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Frequently Asked Questions

What is the CTO definition of a clinical trial?

A clinical trial is any research study that (1) involves a medical intervention/medical care using investigational medical products; and (2) is reasonably expected to need full board or expedited review by the Committee for the Protection of Human Subjects (CPHS), which is the institutional review Board (IRB) at Dartmouth College.

How do I contact the CTO?

You can reach the CTO by calling 653-3411 or emailing CTO@Hitchcock.org.

Who will be my contract and budget contacts?

Contacts are assigned dependent upon the specialty. The CTO will notify the department of the contract and budget contactsupon receipt of the intake form.

What legal documents from sponsors go to the CTO?

CDAs (Non-Disclosures) and CTAs (Contracts) received from sponsors should be sent directly to the CTO at CTO@hitchcock.org.

How long will it take to complete an agreement?

Time to completion of an agreement is variable. Many factors influence the time involved in negotiating the contract - e.g., responsiveness of the sponsor, type of agreement, and whether a prior or master agreement exists. It is our policy to have all application materials in hand and have a Resource Meeting before negotiating the clinical trial agreement.

Can I sign the agreement myself?

No. An authorized CTO official is required to sign all agreements. An agreement signed by the investigator is not valid or enforceable.

Should I contact the CTO prior to Departmental Scientific Review submission for trials?

Yes. If all documents are available, please submit via the intake form. Note that the Resource Meeting will not be scheduled until after Departmental Scientific Review submission and approval.

What is the flow of a new study?

  • The Research Team submits the new study documents to the CTO via the study intake form on the CTO intranet site.
  • Once all documents are received, the Business Operations Assistant contacts the research team to schedule a Resource Meeting. The Assistant also assembles all documents into a binder and gives them to the Business Operations Associate (BOA) for review.
  • The BOA reviews the study and prepares the draft MCA and the draft Billing Grid and starts the Resource Meeting Questionnaire. The Billing Grid and Resource Meeting Questionnaire are forwarded to the Research Team.
  • The BOA and the Research Team meet to discuss the study, review the Resource Meeting Questionnaire, and edit the Draft Billing Grid.
  • Based on information obtained at the Resource Meeting, the BOA updates the Billing Grid and the MCA, and then drafts the Internal Budget.
  • The Internal Budget is transferred to the sponsor's template, and the BOA begins negotiations.
  • The Contract is negotiated simultaneously by the CTO Contract Officers.
  • Once the BOA feels that she/he has negotiated the best Budget possible, it is reviewed with the Research Team, which gives the final approval.
  • The BOA prepares a routing Package that includes the Routing Form, the Internal Budget, the MCA, the Contracting Form, and the Contract, and forwards it to the Research Team. The Research Team obtains all departmental signatures and returns the package to the BOA.
  • Once IRB Approval is obtained, the Research Team forwards the approval letter and stamped consent to the BOA. A final consistency check is performed, research account numbers are obtained, and the study is activated in Velos by the BOA.e Sponsor's templateand the BOA begins negotiations.

How do I submit a new study to the CTO?

Use the intake form.

What documents does the CTO require?

  1. Protocol
  2. Contract (if applicable)
  3. Model Consent
  4. Budget (if applicable) and/or Documentation from website of per patient reimbursement
  5. Approximate date for Department Scientific Review
  6. Lab Manual (if possible)

What is a Resource Meeting?

The Resource Meeting is an opportunity for the study team and Clinical Trials Office to meet to discuss the clinical trial in detail, to review the draft MCA and ensure that all required services are indicated, and to determine what services are Standard of Care vs. Research only.

How far in advance do I have to book a Resource Meeting?

The CTO requires at least 10 business days from date of confirmation.

Will the study team be part of the budget negotiations?

Budget negotiations are conducted by the CTO. However, certain clinical aspects of a trial may require input from the study teamto ensurethat relevant services are budgeted correctly.

When will a PI be asked to be involved in stalled negotiations?

After the BOA makes three attempts for a status on the budget without receiving a response from the sponsor.

How are Federally funded studies handled?

For Federally funded studies, the CTO will complete an MCA and Budget. The budget will include only those patient care charges that have been determined to be research-only; such charges will be indicated on the budget at research rate.

When are the CRC and Research RNs required to give time estimates if applicable?

Before or upon date of the Resource Meeting, all time estimates should be submitted in writing to the Business Operations Associate assigned to the clinical trial.

How do I arrange for Patient Stipends to be paid?

Patient stipends can be paid through Greenphire. Visit our Intranet site for more information. (only available inside the Dartmouth-Hitchcock network)

How do I arrange for Travel/Mileage Reimbursement for patients?

Patient travel and mileage can be reimbursed through Greenphire. Visit our Intranet site for more information. (only available inside the Dartmouth-Hitchcock network)

What do I do if I receive a check for a clinical trial?

For new studies, checks should be sent to the cashier on Level 3 and reference the Clinical Trials Office. For more information, please direct your questions to: cto@hitchcock.org.

What is Velos? Do I have to use it?

Velos is the institution's Clinical Trials Database. Velos providesStudy Administration, Patient Management, and Custom Reports. All clinical research studies should beuploaded to Velos by using the study intake form. To request assistance or training, send a request via email to Velos.NCCC@Dartmouth.EDU

When do I submit documents to CPHS?

You may submit documents to the CPHS for up to 7 business days after the Resource Meeting has taken place. An MCA will be sent to the appropriate Department Contact with a Billing Grid ready for CPHS submission.

How do I submit to CHPS?

Follow the directions on the CPHS website.

How do I reach the Office of Sponsored Projects (OSP)?

Visit the OSP online.

What are the educational requirements for the PIs of a clinical trial?

  • GCP Training: Effective December 31, 2010, Good Clinical Practice (GCP) training is required for all Dartmouth PIs and Key Personnel who are conducting clinical research requiring full committee approval by the CPHS. A study will NOT be approved to proceed until the training requirement for the research team has been met.
  • CPHS education requirements: http://www.dartmouth.edu/~cphs/tosubmit/education/

Do I have to use the Investigational Pharmacy?

Yes, if you are using an investigational drug as a part of your trial.

What is the overhead rate?

The overhead rate is 30 percent.

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