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Human Research and IRB FAQs

What is Human Research?

The “HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)” defines the activities that this organization considers to be “Human Research” as defined in DHHS regulations at 45 CFR §46.102(d) and 45 CFR §46.102(f) and as defined in FDA regulations at 21 CFR §56.102(c) , 21 CFR §56.102(e), and 21 CFR §812.3(p). An algorithm for determining whether an activity is Human Research can be found in the “WORKSHEET: Human Research Determination (HRP-310),” located in the IRB Policies & Procedures section of the IRB Web site. Use this document for guidance as to whether an activity meets either the DHHS or FDA definition of Human Research, keeping in mind that the IRB makes the ultimate determination in questionable cases as to whether an activity constitutes Human Research subject to IRB oversight.

You are responsible not to conduct Human Research without prior IRB review and approval (or an IRB determination that the Human Research is Exempt). If you have questions about whether an activity is Human Research, contact the Office of Regulatory Research Compliance who will provide you with a determination. If you wish to have a written determination, provide a written request to the Office of Regulatory Research Compliance.

What is the Human Research Protection Program?

The document “HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)” describes this organization’s overall plan to protect subjects in Human Research.

  • The mission of the Human Research Protection Program.
  • The ethical principles that the organization follows governing the conduct of Human Research.
  • The applicable laws that govern Human Research.
  • When the organization becomes “engaged in Human Research” and when someone is acting as an agent of the organization conducting Human Research.
  • The types of Human Research that may not be conducted.
  • The roles and responsibilities of individuals within the organization.

What training does my staff and I need to conduct Human Research?

Investigators and staff conducting human subject research must complete the Learner Group Specific online Collaborative Institutional Training Initiative (CITI) human subjects online training program including the “Conflicts of Interest in Research Involving Human Subjects”. The CITI site can be accessed at http://www.drexel.edu/research/compliance/training/. Investigators and staff conducting human subject research must also complete the institution’s training program on financial conflicts of interests CITI training is valid for a two-year period, after which time the training must be repeated. Please note that all members of the research team involved in the design, conduct, or reporting of the research are required to complete training. IRB approval will not be granted for proposed research in which members of the research team have not completed human research protections training.

How do I submit new Human Research to the IRB?

Complete the “FORM: Application for Initial Review (HRP-211),” attach all requested supplements, have the form signed by the individuals listed in the form, and provide the requested documents electronically to the Office of Regulatory Research Compliance. All documents and reports are to be provided to the IRB electronically and can be emailed to hrpp@drexel.edu as well as Cc’d to your specific IRB coordinator. Maintain electronic copies of all information submitted to the IRB in case revisions are required.

Electronic IRB Application Process

How do I write an Investigator Protocol?

Use the “TEMPLATE PROTOCOL (HRP-503)” as a starting point for drafting a new Investigator Protocol, and reference the instructions in italic text for the information the IRB looks for when reviewing research. Here are some key points to remember when developing an Investigator Protocol:

  • The italicized bullet points in the “TEMPLATE PROTOCOL (HRP-503)”” serve as guidance to investigators when developing an Investigator Protocol for submission to the IRB. All italicized comments are meant to be deleted prior to submission.
  • For any items described in the sponsor’s protocol or other documents submitted with the application, investigators may simply reference the page numbers of these documents within the Investigator Protocol rather than repeat information.
  • When writing an Investigator Protocol, always keep an electronic copy. You will need to modify this copy when making changes to the Investigator Protocol.
  • If you believe your activity may not be Human Research, contact the Office of Regulatory Research Compliance prior to developing your Investigator Protocol.
  • Note that, depending on the nature of your research, certain sections of the template may not be applicable to your Investigator Protocol. Indicate this as appropriate.
  • You may not involve any individuals who are members of the following populations as subjects in your research unless you indicate this in your inclusion criteria as the inclusion of subjects in these populations has regulatory implications.
    • Adults unable to consent
    • Individuals who are not yet adults (infants, children, teenagers)
    • Pregnant women
    • Prisoners

How do I create a consent document?

Use the “TEMPLATE CONSENT DOCUMENT (HRP-502)” to create a consent document. Note that all long form consent documents and all summaries for short form consent documents must contain all of the required and all additional appropriate elements of informed consent disclosure. Review the “Long Form of Consent Documentation” section in the IRB’s “WORKSHEET: Criteria for Approval and Additional Considerations (HRP-314),” to ensure that these elements are addressed. When using the short form of consent documentation the appropriate signature block from “TEMPLATE CONSENT DOCUMENT (HRP-502)” should be used on the short form. We recommend that you date the revisions of your consent documents to ensure that you use the most recent version approved by the IRB.

What are the different regulatory classifications that research activities may fall under?

Submitted activities may fall under one of the following four regulatory classifications:

  • Not “Human Research”: Activities must meet the DHHS or FDA definition of “research” involving “human subjects” for the activity to fall under IRB oversight. Activities that meet neither definition of “Research involving “Human Subjects” are not subject to IRB oversight or review. Review the Office of Regulatory Research Compliance’s “WORKSHEET: Human Research Determination (HRP-310)” for reference. Contact the Office of Regulatory Research Compliance in cases where it is unclear whether an activity meets the regulatory definition of Human Research.
  • Exempt: Certain categories of Human Research may be exempt from regulation but require IRB review. It is the responsibility of the IRB, not the investigator, to determine whether Human Research is exempt from IRB review. Review the Office of Regulatory Research Compliance’s “WORKSHEET: Exemption Determination (HRP-312)” for reference on the categories of research that may be exempt.
  • Review Using the Expedited Procedure: Certain categories of non-exempt Human Research may qualify for review using the expedited procedure. Review the Office of Regulatory Research Compliance’s “WORKSHEET: Eligibility for Review Using the Expedited Procedure (HRP-313)” for reference on the categories of research that may be reviewed using the expedited procedure.
  • Review by the Convened IRB: Non-Exempt Human Research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB.

What are the decisions the IRB can make when reviewing proposed research?

The IRB may approve research, require modifications to the research to secure approval, table research, or disapprove research:

  • Approval: Made when all criteria for approval are met. See “How does the IRB decide whether to approve Human Research?” below.
  • Modifications Required to Secure Approval: Made when IRB members require specific modifications to the research before approval can be finalized.
  • Tabled: Made when the IRB cannot approve the research at a meeting for reasons unrelated to the research, such as loss of quorum. When taking this action, the IRB automatically schedules the research for review at the next meeting.
  • Deferred: Made when the IRB determines that the board is unable to approve research and the IRB suggests modifications the might make the research approvable. When making this motion, the IRB describes its reasons for this decision, describes modifications that might make the research approvable, and gives the investigator an opportunity to respond to the IRB in person or in writing.
  • Disapproval: Made when the IRB determines that it is unable to approve research and the IRB cannot describe modifications the might make the research approvable. When making this motion, the IRB describes its reasons for this decision and gives the investigator an opportunity to respond to the IRB in person or in writing.

How does the IRB decide whether to approve Human Research?

The criteria for IRB approval can be found in the “WORKSHEET: Exemption Determination (HRP-312)” for exempt Human Research and the “WORKSHEET: Criteria for Approval and Additional Considerations (HRP-314)” for non-exempt Human Research. The latter worksheet references other checklists that might be relevant. All checklists and worksheets can be found on the IRB Web site.

These checklists are used for initial review, continuing review, and review of modifications to previously approved Human Research. You are encouraged to use the checklists to write your Investigator Protocol in a way that addresses the criteria for approval.

What will happen after IRB review?

The IRB will provide you with a written decision indicating that the IRB has approved the Human Research, requires modifications to secure approval, or has disapproved the Human Research.

  • If the IRB has approved the Human Research: The Human Research may commence once all other organizational approvals have been met. IRB approval is usually good for a limited period of time which is noted in the approval letter.
  • If the IRB requires modifications to secure approval and you accept the modifications: Make the requested modifications and submit them to the IRB. If all requested modifications are made, the IRB will issue a final approval. Research cannot commence until this final approval is received. If you do not accept the modifications, write up your response and submit it to the IRB.
  • If the IRB defers the Human Research: The IRB will provide a statement of the reasons for deferral and suggestions to make the study approvable, and give you an opportunity to respond in writing. In most cases if the IRB’s reasons for the deferral are addressed in a modification, the Human Research can be approved
  • If the IRB disapproves the Human Research: The IRB will provide a statement of the reasons for disapproval and give you an opportunity to respond in writing.

In all cases, you have the right to address your concerns to the IRB directly at an IRB meeting.

What are my obligations after IRB approval?

  1. Do not start Human Research activities until you have the final IRB approval letter.
  2. Do not start Human Research activities until you have the approval of departments or divisions that require approval prior to commencing research that involves their resources.
  3. Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
  4. Ensure that Research Staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study.
  5. Update the IRB office with any changes to the list of study personnel.
  6. Personally conduct or supervise the Human Research.
    1. Conduct the Human Research in accordance with the relevant current protocol as approved by the IRB.
    2. When required by the IRB ensure that consent or permission is obtained in accordance with the relevant current protocol as approved by the IRB.
    3. Do not modify the Human Research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subjects.
    4. Protect the rights, safety, and welfare of subjects involved in the research.
  7. Submit to the IRB:
    1. Proposed modifications as described in this manual. (See “How do I submit a modification?”)
    2. A continuing review application as requested in the approval letter. (See “How do I submit continuing review?”
    3. A continuing review application when the Human Research is closed. (See “How Do I Close Out a Study?”)
  8. Report the any of the information items in on the back of “FORM: Reportable New Information (HRP-214)” to the IRB within five business days.
  9. Submit an updated disclosure of financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.
  10. Do not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”)
  11. Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment (“bonus payments.”)
  12. See additional requirements of various federal agencies in Appendix A

How do I document consent?

Use the signature block approved by the IRB. Complete all items in the signature block, including dates and applicable checklists. The following are the requirements for long form consent documents:

  • The subject or representative signs and dates the consent document.
  • The individual obtaining consent signs and dates the consent document.
  • Whenever required by the IRB the subject’s or representative’s signature is to be witnessed by an individual who signs and dates the consent document.
  • For subjects or read who cannot read and whenever required by the IRB or the sponsor, a witness to the oral presentation signs and dates the consent document.
  • A copy of the signed and dated consent document is to be provided to the subject.

The following are the requirements for short form consent documents:

  • The subject or representative signs and dates the short form consent document and the summary.
  • The individual obtaining consent signs and dates the short form consent document and the summary.
  • The witness to the oral presentation signs and dates the short form consent document and the summary.
  • Copies of the signed and dated consent document and summary are provided to the subject or representative.

How do I submit a modification?

Complete the “FORM: Modification of Approved Research (HRP-213),” attach all requested supplements, have the formed signed by the individuals listed in the form, and provide the requested documents electronically to the Office of Regulatory Research Compliance. All documents and reports are to be provided to the IRB electronically and can be emailed to hrpp@drexel.edu as well as Cc’d to your specific IRB coordinator.

Maintain electronic copies of all information submitted to the IRB in case revisions are required. Please note that research must continue to be conducted without inclusion of the modification until IRB approval is received. Updates to the list of study personnel will be acknowledged unless the update represents a modification to the research.

Electronic IRB Application Process

How do I submit continuing review?

Complete the “FORM: Continuing Review Progress Report (HRP-212),” attach all requested supplements, have the formed signed by the individuals listed in the form, and provide the requested documents electronically to the Office of Regulatory Research Compliance. All documents and reports are to be provided to the IRB electronically and can be emailed to hrpp@drexel.edu as well as Cc’d to your specific IRB coordinator.

Maintain electronic copies of all information submitted to the IRB in case revisions are required. If the continuing review involves modifications to previously approved research, submit those modifications as a separate request for modification using the “FORM: Modification of Approved Research (HRP-213).”

If the continuing review application is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application has been received. If the approval of Human Research expires all Human Research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Continuing Human Research procedures is a violation of federal regulations. If current subjects will be harmed by stopping Human Research procedures that are available outside the Human Research context, provide these on a clinical basis as needed to protect current subjects. If current subjects will be harmed by stopping Human Research procedures that are not available outside the Human Research context, immediately contact the IRB chair and provide a written list of the currently enrolled subjects and why they will be harmed by stopping Human Research procedures.

Electronic IRB Application Process

How do I close out a study?

Complete the “FORM: Continuing Review Progress Report (HRP-212),” attach all requested supplements, have the formed signed by the individuals listed in the form, and provide the requested documents electronically to the Office of Regulatory Research Compliance. All documents and reports are to be provided to the IRB electronically and can be emailed to hrpp@drexel.edu as well as Cc’d to your specific IRB coordinator.

Maintain electronic copies of all information submitted to the IRB in case revisions are required. If you fail to submit a continuing review form to close out Human Research, you will be restricted from submitting new Human Research until the completed application has been received. If the continuing review application for closing out a Human Research study is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application is received.

Electronic IRB Application Process

How long do I keep records?

Maintain your Human Research records, including signed and dated consent documents for at least three years after completion of the research. Maintain signed and dated HIPAA authorizations and consent documents that include HIPAA authorizations for at least six years after completion of the research.

If your Human Research is sponsored contact the sponsor before disposing of Human Research records.

What if I need to use an unapproved drug, biologic, or device and there is no time for prior IRB review?

Contact the IRB Office or IRB chair immediately to discuss the situation. If there is no time to make this contact, see the “WORKSHEET: Emergency Use (HRP-322)” for the regulatory criteria allowing such a use and make sure these are followed. Use the “TEMPLATE EMERGENCY USE CONSENT DOCUMENT (HRP-506)” to prepare your consent document. You will need to submit a report of the use to the IRB within five days of the use and for drugs and biologics, submit an IRB application for initial review within 30 days.

If you fail to submit the report within five days or the IRB application for initial review within 30 days, you will be restricted from submitting new Human Research until the report and IRB application for initial review have been received.

Emergency use of an unapproved drug or biologic in a life-threatening situation without prior IRB review is “research” as defined by FDA, the individual getting the test article is a “subject” as defined by FDA, and therefore is governed by FDA regulations for IRB review and informed consent. Emergency use of an unapproved device without prior IRB review is not “research” as defined by FDA and the individual getting the test article is not a “subject” as defined by FDA. However, FDA guidance recommends following similar rules as for emergency use of an unapproved drug or biologic. Individuals getting an unapproved drug, biologic, or device without prior IRB review cannot be considered a “subject” as defined by DHHS and their results cannot be included in prospective “research” as that term is defined by DHHS.

How do I get additional information and answers to questions?

This document and the policies and procedures for the Human Research Protection Program are available on the IRB Web Site at www.research.drexel.edu/compliance. If you have any questions or concerns, about the Human Research Protection Program, contact the Office of Regulatory Research Compliance at:

Office of Regulatory Research Compliance
1601 Cherry Street
Philadelphia, PA 19102
(215) 255-7857
hrpp@drexel.edu

If you have questions, concerns, complaints, allegations of undue influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program that cannot be addressed by contact the Office of Regulatory Research Compliance, follow the directions in the “HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)” under “Reporting and Management of Concerns.”

Additional Requirements for DHHS-Regulated Research

  1. When a subject decides to withdraw from a clinical trial, the investigator conducting the clinical trial should ask the subject to clarify whether the subject wishes to withdraw from all components of the trial or only from the primary interventional component of the trial. If the latter, research activities involving other components of the clinical trial, such as follow-up data collection activities, for which the subject previously gave consent may continue. The investigator should explain to the subject who wishes to withdraw the importance of obtaining follow-up safety data about the subject.
  2. Investigators are allowed to retain and analyze already collected data relating to any subject who chooses to withdraw from a research study or whose participation is terminated by an investigator without regard to the subject’s consent, provided such analysis falls within the scope of the analysis described in the IRB-approved protocol. This is the case even if that data includes identifiable private information about the subject.
  3. For research not subject to regulation and review by FDA, investigators, in consultation with the funding agency, can choose to honor a research subject’s request that the investigator destroy the subject’s data or that the investigator exclude the subject’s data from any analysis.

When seeking the informed consent of subjects, investigators should explain whether already collected data about the subjects will be retained and analyzed even if the subjects choose to withdraw from the research.

Additional Requirements for FDA-Regulated Research

  1. When a subject withdraws from a study:2
    1. The data collected on the subject to the point of withdrawal remains part of the study database and may not be removed.
    2. An investigator may ask a subject who is withdrawing whether the subject wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the subject would distinguish between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the subject’s information.
    3. If a subject withdraws from the interventional portion of the study, but agrees to continued follow-up of associated clinical outcome information as described in the previous bullet, the investigator must obtain the subject’s informed consent for this limited participation in the study (assuming such a situation was not described in the original informed consent form). IRB approval of informed consent documents is required.
    4. If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access for purposes related to the study the subject’s medical record or other confidential records requiring the subject’s consent.
    5. An investigator may review study data related to the subject collected prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status.
  2. For FDA-regulated research involving investigational drugs:
    1. Investigators must abide by FDA restrictions on promotion of investigational drugs:3
      1. An investigator, or any person acting on behalf of an investigator, must not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.
      2. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.
      3. An investigator must not commercially distribute or test market an investigational new drug.
    2. Follow FDA requirements for general responsibilities of investigators4
      1. An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
      2. An investigator must, in accordance with the provisions of 21 CFR §50, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 21 CFR §50.23 or §50.24 of this chapter.
      3. Additional specific responsibilities of clinical investigators are set forth in this part and in 21 CFR §50 and 21 CFR §56.
    3. Follow FDA requirements for control of the investigational drug5
      1. An investigator must administer the drug only to subjects under the investigator's personal supervision or under the supervision of a sub-investigator responsible to the investigator.
      2. The investigator must not supply the investigational drug to any person not authorized under this part to receive it.
    4. Follow FDA requirements for investigator recordkeeping and record retention6
      1. Disposition of drug:
        1. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.
        2. If the investigation is terminated, suspended, discontinued, or completed, the investigator must return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under 21 CFR §312.59.
      2. Case histories.
        1. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
        2. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital charts, and the nurses' notes. The case history for each individual must document that informed consent was obtained prior to participation in the study.
      3. Record retention: An investigator must retain required records for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
    5. Follow FDA requirements for investigator reports7
      1. Progress reports: The investigator must furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained.
      2. Safety reports: An investigator must promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator must report the adverse effect immediately.
      3. Final report: An investigator must provide the sponsor with an adequate report shortly after completion of the investigator's participation in the investigation.
      4. iv.
      5. Financial disclosure reports:
        1. The clinical investigator must provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required under 21 CFR §54.
        2. The clinical investigator must promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.
    6. Follow FDA requirements for assurance of IRB review8
      1. An investigator must assure that an IRB that complies with the requirements set forth in 21 CFR §56 will be responsible for the initial and continuing review and approval of the proposed clinical study.
      2. The investigator must also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
    7. Follow FDA requirements for inspection of investigator's records and reports9
      1. An investigator must upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to 312.62.
      2. The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.
    8. Follow FDA requirements for handling of controlled substances10
      1. If the investigational drug is subject to the Controlled Substances Act, the investigator must take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.
  3. For FDA-regulated research involving investigational devices:
    1. General responsibilities of investigators.11
      1. An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with 21 CFR §50.
    2. Specific responsibilities of investigators12
      1. Awaiting approval: An investigator may determine whether potential subjects would be interested in participating in an investigation, but must not request the written informed consent of any subject to participate, and must not allow any subject to participate before obtaining IRB and FDA approval.
      2. Compliance: An investigator must conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
      3. Supervising device use: An investigator must permit an investigational device to be used only with subjects under the investigator's supervision. An investigator must not supply an investigational device to any person not authorized to receive it.
      4. Financial disclosure:
        1. A clinical investigator must disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required under 21 CFR §54.
        2. The investigator must promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study.
      5. Disposing of device: Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator must return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.
    3. Maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:13
      1. All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports.
      2. Records of receipt, use or disposition of a device that relate to:
        1. The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
        2. The names of all persons who received, used, or disposed of each device.
        3. Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
      3. Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital charts, and the nurses' notes. Such records must include:
        1. Documents evidencing informed consent and, for any use of a device by the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent.
        2. Documentation that informed consent was obtained prior to participation in the study.
        3. All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of, the investigation, including information about relevant previous medical history and the results of all diagnostic tests.
        4. A record of the exposure of each subject to the investigational device, including the date and time of each use, and any other therapy.
      4. The protocol, with documents showing the dates of and reasons for each deviation from the protocol.
      5. Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation.
    4. Inspections14
      1. Entry and inspection: A sponsor or an investigator who has authority to grant access must permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept).
      2. Records inspection: A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, must permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation.
      3. Records identifying subjects: An investigator must permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading.
    5. Prepare and submit the following complete, accurate, and timely reports15
      1. Unanticipated adverse device effects. An investigator must submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.
      2. Withdrawal of IRB approval. An investigator must report to the sponsor, within 5 working days, a withdrawal of approval by the reviewing IRB of the investigator's part of an investigation.
      3. Progress. An investigator must submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly.
      4. Deviations from the investigational plan:
        1. An investigator must notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency.
        2. Such notice must be given as soon as possible, but in no event later than 5 working days after the emergency occurred.
        3. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human subjects, FDA and IRB also is required.
      5. Informed consent. If an investigator uses a device without obtaining informed consent, the investigator must report such use to the sponsor and the reviewing IRB within 5 working days after the use occurs.

[1] http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html
[2] http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126489.pdf
[3] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.7
[4] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.60
[5] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.61
[6] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.62
[7] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.64
[8] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.66
[9] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.68
[10] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.69
[11] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.100
[12] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.110
[13] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.140
[14] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.145
[15] http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.150