Site Submission Form– Short Form

Completion Guidelines

To be completed for Phase IV Studies

These guidelines have been prepared to assist you with the completion of Harrison IRB’s Site Submission Form – Short Form. Please answer all of the questions in this form to minimize any delay in processing your site’s submission. Harrison IRB has also provided these guidelines on its website under the “Sites” tab. If you have any additional questions, please do not hesitate to contact Harrison IRB at (740) 845 0814.

  1. Principal Investigator Information

Please provide the contact information for the Principal Investigator and site as you would like for the information to appear on all IRB-related documentation.

  • The Principal Investigator (PI) is the individual who will be directly responsible for directing the research at his/her site. The Principal Investigator is also the name listed on the FDA Form 1572.
  • Site Contact for Correspondence* is the individual who will be responsible to receive all IRB-related documentation.

*Harrison IRB prefers that the Principal Investigator not be listed as the contact person, but rather a representative that is easily accessible to answer questions regarding the submission documents and who would be able to correspond with the Investigator to answer questions/queries, etc. on behalf of the sites.

2. Additional Sites (if applicable)

  • The Additional Site Form must be completed if study activities will be conducted at other facilities under the Principal Investigator’s guidance for this research. Please note that the additional site or sites must be listed in Section 3 of the FA Form 1572. The Additional Site Form is available on Harrison IRB’s website at
  • The Waiver of IRB Jurisdiction only applies to those sites that have their own IRB (usually a hospital or university). All submissions that list a hospital or university as a Site Name or Additional Site will require that a representative of Harrison IRB contact you to confirm the requirement of a Waiver of IRB Jurisdiction. The Waiver of IRB Jurisdiction is available on Harrison IRB’s website at

3. Site Activities/Information

In sections b. and c., please note all action s that will be taken at the site to ensure that study data is kept confidential and your provisions to protect to the privacy interest of subjects in the research.

4. Vulnerable Populations

  • Select from the list of potential populations that may be enrolled at your site. When consenting non-English speaking patients, an interpreter must be available to review the consent with the patient, participate in the consent process and answer any study-related questions from patient and/or family member(s). If you are requesting a translation of study documents into another language (#11), you must select the Non-English speaking category in this section.
  • If your site is recruiting vulnerable populations for this research, you must provide a thorough account of the additional measures to ensure vulnerable populations are protected.

5. Informed Consent Form (ICF) and Process

  • Attach or insert into the text box your Standard Operating Procedure (SOP) for obtaining informed consent/assent. Your SOP should explain in detail how you consent subjects. Please address each bullet point listed in this section to ensure a thorough answer for obtaining your consent.

For more information regarding informed consent, please visit the FDA’s website:

  • Please provide site specific changes (other than site contact information and stipend) by noting the changes on the hard copy of the template informed consent form or by tracked changes to the Word document if it has been provided to your site.
  • Please list the phone numbers that will be listed on the informed consent form for subjects to contact you during normal office hours and after hours in the case of an emergency.
  • You may note that the after hours number is the “same” as the office number, but if there is no number listed for the after hours number, we will be required to contact you to confirm that subjects will be able to reach someone during an emergency.

6. Subject Compensation

Stipend information will be incorporated into the Informed Consent Document for your site and must be as accurate as possible.

  • Dollar Amount Per Visit….: The amount per visit “times” the number of visits must equal the total amount paid. There are occasions when the site may not reimburse for a study visit (i.e., Screening Visit), so this must be documented. Please provide as much detail as possible to minimize IRB site queries.
  • Payment will be made: It is important that the sites complete this section as well because the information is listed on the ICF.

7. FDA Audit Documentation

  • Please complete this section and provide additional documentation of past FDA audits that were conducted at your site in the past 5 years. If you have recently completed and audit and have not received correspondence from the FDA, please make a notation on the form.

8. Translations

Harrison IRB will translate the template informed consent document at the Sponsor’s request. If the Sponsor authorizes the translation of study materials, the site will be provided with a document that is populated with the site’s specific contact information and stipend. Please note that if your site requires additional changes to the informed consent form and requests translation of the consent, Harrison IRB must receive approval from the Sponsor prior to translating the document and sending to your site.

If requesting a translation of documents for your site, please note that Harrison IRB requires that a qualified translator is available for participants throughout the research. This person must be available to discuss the research study, the contents of the informed consent documents and study related materials and can answer any questions the subject may have regarding the study in the language of the participant.

9. Conflict of Interest

  • Harrison IRB provides a link on its website to direct Investigators to the FDA website with guidelines for “Financial Disclosure by Clinical Investigators. This information is helpful if you have any questions regarding the “Conflict of Interest” section in our Site Submission Form.
  • Immediate family members is defined as spouse and each dependent child
  • Financial and non-financial criteria may be reviewed by Harrison IRB to determine Conflict of Interest. Examples include:
  • Financial interest in the research with value that cannot be readily determined
  • A financial interest in the research with value that exceeds a specified monetary threshold
  • Has received or will receive compensation with value that may be affected by the outcome of the study
  • A proprietary interest in the research, such as a patent, trademark, copyright or licensing agreement
  • Has received or will receive payments from sponsor that exceed a specified monetary threshold in a specified period of time
  • Being an executive or director of the agency or company sponsoring the research
  • A financial interest that requires disclosure to the sponsor or funding source
  • Has any other financial interest that the investigator believes may interfere with his or her ability to protect participants.
  • Changes to financial conflict of interest must be reported to Harrison IRB within 10 business days of the conflict by submitting the Site Information Change Request Form available on the website.

Statement From Investigator

The PI must sign and date the Site Submission Form to validate the application.

For any questions regarding the submission of your site for an upcoming study, please do not hesitate to contact Harrison IRB at (740) 845-0814.

Site Submission Form - Short Form Completion Guidelines Page 1 of 4

Version 5, dated May 29, 2009