Sponsors FAQs

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Schulman is capable of receiving all documents via Email. Secure Electronic Submission is available for submission of sensitive documents. Schulman acknowledges by email all electronic new protocol and research site submissions. If a signature is required, you must scan the signature page of the document into PDF format before submitting it electronically. If you are unable to scan the signature page of the document into PDF format, you may fax it to the appropriate team at Schulman. All Schulman forms are available in both PDF and Word format. The completed forms should be submitted to the following teams:

• Submission Forms - Submission Team
• Recruitment/Study Related Forms - Recruitment Team
• Revised FDA 1572/Non-IND/Device Forms - Amendments Team
• Amendments Submission Forms - Amendments Team
• Report Forms
  • Study Status Report Form - Document Management Team
  • Protocol Deviation Report Form - Regulatory Affairs Team
  • Product Safety Report Form - Product Safety Team

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The Board meets weekly to review new studies (protocols) on Wednesday and Friday mornings. Due to some holiday schedules and unforeseen conflicts, however, the Board may not meet every Wednesday and Friday. Accordingly, it is best to check our website regularly for the schedule of meetings. Schulman must receive all new protocol submissions no later than noon (12:00 p.m. EST), one week before the meeting date (i.e., Schulman must be in receipt of all documents by Wednesday at noon, one (1) week prior to a Wednesday meeting date, or by Friday at noon, one (1) week prior to a Friday meeting date).

Timely review by the Board is dependent upon your complete submission of all required documents. The Board will not review a study until all appropriate documentation is received. If any documentation is missing, Schulman staff will contact the submitting party. Until the Board receives all necessary documents, a meeting date to review your study will not be assigned.

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The standard turn-around-time for review of a new protocol and informed consent document is approximately two weeks. This allows one week for administrative processing and circulation to the Board for review, and one week after the Board meeting for preparation and transmission of study documents to the submitting party. Turn-around-time is dependent upon complete and accurate submission of study documents, and may be extended if the Board, upon review, requires further information.

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The submitting party will be contacted (via fax, email, etc.) regarding the status of a new study within one business day after the initial review of the protocol and informed consent document (ICD) by the Board. This notification will include the Board decision regarding the review of the study (Approved, Conditionally Approved, On Hold or Disapproved) and will outline additional information requested by the Board, if applicable.

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If the Board approves a new study, the draft ICD will be sent to the submitting party within four (4) to six (6) business days of the meeting date. Several factors may affect this timing, for example, Board requested clarifications, satisfaction of conditions of approval or holidays.

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Under federal regulations, the Board has the authority to revise the submitted ICD. The Board may make changes to an ICD template to make it easier to read and/or more understandable to a study subject. The Board tries, whenever possible, to use layman's terms to describe the study design, procedures and risks. The Board also may modify language to ensure that the document includes the required basic elements of an informed consent.

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The submission deadline for an additional site of a previously approved protocol is 4 p.m. EST. If a site submission is received after the 4 p.m. EST deadline, it will be recorded as received on next business day.

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Additional sites conducting a protocol previously reviewed by the Board are not required to submit a copy of the ICD. Schulman will provide each approved research site with a site-specific ICD using the template ICD as approved by Schulman with the addition of the investigator's name, emergency contact numbers and site-specific compensation for participation.

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• Incomplete submission documents can delay the review of your materials. Please refer to the Submission Checklist to ensure that you are submitting all required documents for the review of new studies and additional sites.
• The Board may identify areas of concern with the protocol and place a study on hold or conditionally approve a study pending receipt of further information.
• Upon approval of a study, Board modifications to the informed consent document (ICD) are made. A draft of the ICD is forwarded to the submitting party for review. If upon review of the draft ICD, the submitting party would like to request further modification, this can be done using the track changes feature to enter the text in the consent document, by noting the changes on the hardcopy of the ICD or in a detailed memo accompanying it. Please return these requested revisions with the provided coversheet. A Board member must review any requested changes. Until the Board approves the ICD language, approval documents will not be sent to any sites.
• Upon review of additional sites conducting a previously approved protocol, the Board may note an area of concern with the site's responses on the submission documents. If concerns are noted or the compensation for participation information is unclear, a Schulman representative will contact the site. The site must provide satisfactory resolution of the identified issues before the approval process can be completed.
• If a site submits a request for additional site-specific revision(s) to an ICD, a Board member must review the requested revision(s) to determine appropriateness of the requested revision(s).

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If a sponsor or CRO needs an electronic version of the approved ICD, please provide a request via e-mail identifying the intended use of the electronic version of the ICD. The request will be reviewed. If approved, SAIRB will provide a template electronic consent, which will contain language on each page indicating that the template is "not for use in consenting subjects." The electronic consent will then be forwarded to the designated party at the sponsor/CRO.

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Schulman will provide an approval letter for the protocol and a copy of the approved template ICD directly to the sponsor/CRO via an overnight delivery service or via the Schulman Portal.

 

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Upon request, Schulman will provide a copy of its Fee Schedule.

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For multi-center studies, centralized billing for Schulman review of protocol-related items for all sites is the preferred method. Please provide the name and contact information for the designated sponsor/CRO personnel responsible for receiving study-related invoices on the Sponsor/CRO New Study Submission Form.

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No, a hospital may assign jurisdiction to another IRB, but it must be done in writing.

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Yes. You may send a Freedom of Information Act request to FDA to obtain a computer generated list of the dates and results of FDA audits of IRBs.

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No. Only institutions that receive federal funding for human subject research are required to have Federal-Wide Assurances ("FWAs") on file with the Office for Human Research Protections ("OHRP"). An FWA is a written document by which an institution agrees to comply with appropriate ethical standards (such as The Belmont Report and The Declaration of Helsinki) and the procedural standards set forth in the federal regulations at 45 CFR 46.

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1.) Research that presents no more than minimal risk and is listed in a National Institutes of Health guidance document as an "adjunct" to the DHHS and FDA regulations; 2.) "minor changes" to previously approved research during the period (one year or less) for which approval is granted; and 3.) some materials used for subject recruitment.

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Yes. However, FDA states that the sponsor/CRO should inform the second institutional review board that another institutional review board previously disapproved the study.

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State laws that relate to:

• age of consent/children's assent
• capacity to consent/legally authorized representatives
• HIV/STD reporting requirements
• confidentiality of medical records
• informed consent
• clinical research
• genetic research
• referral fees
• recruitment methods
• Institutional review boards
• investigational drugs
• vulnerable subjects
• medical practice and delegation of authority to perform procedures

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Yes. The informed consent document must be provided in a language understandable to the study subject.

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Information that is relevant to a non-local IRB about a research site includes the education and training of all study personnel, the site's history and experience in conducting clinical research, FDA inspection reports, type of demographics the site will encounter, and safeguards for vulnerable subjects. This information is captured on the Research Site Submission Form. The Board may request, in certain situations, a site visit be conducted.

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An LAR is an individual or judicial or other body authorized under applicable state law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

For a study in which the IRB determines an LAR is appropriate for decisionally-impaired adults, it is, initially, up to the Investigator to determine that an adult is, in fact, decisionally-impaired and, therefore, unable to consent to study participation. This determination must be documented in the individual's study record. The LAR may then participate in the informed consent process and, when fully informed, decide whether or not to consent on behalf of the potential subject.

An LAR "stands in the shoes" of the decisionally-impaired person and makes decisions on his/her behalf. Who may act as an LAR varies with the law of the state in which the research is being conducted. Therefore, the research staff should be familiar with its own state law in this area. In general, a person who has been appointed by the subject (when the subject was competent) under an advance directive, such as a durable power of attorney for health care, may consent to the procedures to be performed in a research study. Also, most states would recognize a person who has been appointed legal guardian of the potential subject to consent to such procedures. Many states have laws that set forth a hierarchy of persons who may consent to medical procedures when an individual is unable to consent for himself/herself. The hierarchy generally includes a person named under an advance directive, a majority of adult children reasonably available, parents, majority of adult siblings, etc., in order of priority.

A research study may require the involvement of the subject's caregiver. The caregiver may or may not be the subject's LAR . It is the Investigator's responsibility to determine if the caregiver has the authority to act as a decisionally-impaired subject's LAR under your state's law.

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Study Status Reports are normally required every 6 months, unless the Board determines otherwise. Please refer to the most recent approval / reapproval letter to determine when the next Study Status Report is due. Study Status Reports should be submitted 8 weeks prior to the due date to allow time for processing.

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Yes. Schulman's OHRP registration number is 00000971.

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Yes. For some forms, a guide to completing the form is also available. Please see Forms for these guidelines.

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Compensation is evaluated by the Board on a study-by-study basis. Please review the schedule of visits outlined in the protocol before deciding compensation amounts. Compensation should be pro-rated and based on time and inconvenience to the subject.

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IBs are not approved by the Board, therefore only an acknowledgement of receipt is provided. Acknowledgement of receipt will be provided for all IBs included with the initial protocol submission. Acknowledgment of receipt for revised IBs is provided to the submitting party in the same method the IB is received. If an IB is received by hard copy, a self-addressed stamped envelope or pre-paid courier service envelope must be included with the submission in order to receive acknowledgement of receipt. If an IB is received by fax, a fax number must be indicated on the accompanying Product Safety Submission Form. If an IB is received via Email or Secure Electronic Submission, acknowledgement of receipt will be provided via email.

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Acknowledgements of receipt of IBs are provided to the submitting party in the same method the IB is received. If an IB is received by hard copy, a self-addressed stamped envelope or pre-paid courier service envelope must be included with the submission in order to receive acknowledgement of receipt. If an IB is received by fax, a fax number must be indicated on the accompanying Product Safety Submission Form in order to receive acknowledgement of receipt. If an IB is received via Email or Secure Electronic Submission, acknowledgement of receipt will be provided via email.