Frequently Asked Questions
What protocol deviations or violations are required to be reported?
Protocol deviations or violations that either increase the risk to subjects or affect the integrity of the study data must be reported to the IRB. IRBs deem any deviation/violation from the protocol that increases the risk to subjects or affects the integrity of the study data to be significant. An isolated issue may not be significant by itself but significance may increase with numerous deviations of the same nature. Significant deviations may be events such as: enrollment of subjects who did not meet inclusion/exclusion criteria, use of the wrong informed consent document, or failure to perform appropriate procedures at a study visit. Submissions should be made on the IRB’s Protocol Deviation Report Form and Investigators should submit information to the IRB within 10 working days after becoming aware of a significant protocol deviation.
What are the requirements for reporting adverse events?
All adverse events that are BOTH unexpected and serious are reported to the IRB. Investigators must submit information to the IRB within 10 working days for any event that occurs at your site that is BOTH serious AND unexpected. An unexpected SAE is an adverse event that meets the definition of serious but does not appear as a potential risk in the protocol, clinical investigator brochure (CIB), package insert (if applicable) or the most recent informed consent document for the study. When the report is sent to the IRB, the IRB will review the unexpected SAE and determine whether additional risks to the subjects require a revision to the Subject Information and Consent Form.
Events which are BOTH serious AND unexpected should be faxed to the IRB using the IRB SAE Submission coversheet and attaching either the sponsor’s SAE form or the IRB SAE Form. If the SAE is reported without using the IRB SAE Submission coversheet, the investigator must note a determination of whether they determine the SAE is unexpected or expected. If the SAE being reported does not meet the IRB’s submission criteria (i.e. serious but expected), it will be placed in the project file without IRB review.
Follow-up information for events that meet the criteria of serious AND unexpected also must be submitted for SAEs that have pertinent changes (such as a change in resolution status or outcome).
What is the policy for reporting IND Safety reports?
The IRB should be notified of an IND Safety Report within 10 working days. Per ICH Guidelines, in some instances the sponsor may choose to submit the IND safety reports directly to the IRB. Unless the sponsor has made arrangements to submit IND Safety reports on behalf of all sites for a study, each Investigator must forward copies of all IND Safety Reports to the IRB. This ensures a timely review so that a risk assessment is made to determine if a change in the informed consent document is needed. After this review all investigators receive a written notice acknowledging the review.
What are the “rights” of a research subject?
If you decide to be in a research study, you should carefully read and discuss the IRB approved Subject Information and Consent Form with the study staff and study doctor before having any procedures done. Any questions you have should be answered. The decision of whether to take part in the study is completely voluntary. You and only you should make this decision. As a research subject, you have a right to information about the study procedures, study drug, risks and benefits of the study, alternative treatment, confidentiality and any payment that may be provided for taking part. If you do not understand why something is being done during the study…ask. If you decide to take part in a study, you also have a right to withdraw from the study at any time. (See FDA)
What do we mean when we discuss Quality Assurance in research?
There is a system of checks and balances in place for the conduct of clinical research. Federal Regulations and guidelines make up part of this system. Quality assurance (QA) professionals use these tools as they conduct audits to assess compliance with Good Clinical Practice (GCP).
What is HIPAA?
HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. This regulation, also called the Privacy Rule, outlines the standards for privacy of individually identifiable health information. The specific regulations for HIPAA are in Title 45 CFR Parts 160 and 164.
As a Clinical Investigator, what do I need to do to ensure that I am compliant with HIPAA?
(This answer is based on the assumption that the Clinical Investigator is a Covered Entity as defined by the regulations.) As a Clinical Investigator you need to ensure, beginning April 14, 2003, that you obtain proper authorization from the patient/subject entering a research protocol to use his/her PHI for research. This authorization must be obtained by you from all research subjects who are enrolled into clinical trials on or after April 14th 2003. For your ongoing studies under the approval of the IRB, you must use the IRB’s approved authorization form, or your authorization must be submitted to the IRB for review and be approved prior to its use.
In addition, any time you plan to use or disclose PHI [individually identifiable health information] as a result of your identifying potential subjects prior to their recruitment, you must follow a plan permitted by HIPAA. For example, to identify potential subjects for inclusion in your research protocol, you would likely need to review the patient’s existing health information. If any of this PHI used to identify potential subjects and/or to recruit subjects is to leave your research site, such as when it is sent to the study sponsor, you must either obtain the subject’s written authorization for this to occur or you must obtain from the IRB a waiver or alteration of authorization (see waiver of authorization below).
If no PHI will leave your site without prior subject authorization, then you should simply notify your site administrator or whoever represents your covered entity, using the guidance for a review preparatory to research (see below). Note that this notification may occur verbally or in writing.
Lastly, it is also your obligation to be aware of any state and local laws that raise the standard that HIPAA has set forth.
What is a review preparatory to research?
This is a specific term related to the review of a potential subject’s PHI [individually identifiable health information] in order to prepare a research protocol or for similar purposes such as to determine whether the person might be eligible for participation in a research study. By following the requirements for a review preparatory to research, you will comply with HIPAA as you seek to identify potential subjects whose PHI will not leave your site without the person’s prior authorization. Note that this method must not be used if such PHI will leave your site without the person’s prior authorization.
The requirements for complying with this approach are as follows:
• Notification of your Covered Entity that the review of PHI is needed in order for you to prepare a research protocol or for similar purposes such as to determine whether a person might be eligible for participation in a research study.
• Notification that the PHI will be used solely for this review preparatory to research.
• Notification that the PHI is necessary for the purposes of this review.
• Notification that the PHI will not leave your Covered Entity.
Note that CGIRB is not involved in this activity. We only include this information as a service to you.
How can I determine if my organization is a covered entity?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA – The Privacy Rule) applies to any entity that is:
• a health care provider that conducts certain transactions in electronic form (called here a “covered health care provider”)
• a health care clearinghouse
• a health plan
An entity that is one or more of these types of entities is referred to as a “covered entity” in the regulations. Decision tool to assist you in deciding whether or not your organization is a covered entity is available at:
How am I compensated (Investigator)?
Sound Medical Research is very conscious of compensation to its investigators. We have developed the Investigator Payment Program. This program has been created to more easily navigate and project payment from SMR.
Each study you accept will be presented as an addendum to your contract. The addendum will outline the contract payment percentages along with an anticipated Physician Involvement Schedule. This schedule will show the expectations of the physicians and total anticipated time expected for each patient.