emory university va medical case report patient consent

by Laila Hand 6 min read

Informed Consent Process | Emory University | Atlanta GA

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Should case reports be published without consent of the patient?

Historically, case reports were published without consent of the patient. However, standards have been evolving in law and ethics such that consent should now be viewed as mandatory. The remainder of the present commentary provides justification for this assertion.

How long does Emory keep research records?

Emory requires research records be stored for 10 years after study closure or termination. For studies involving children, in-vitro specimens, or pregnant women, Emory requires storage of research records for 25 years.

What is a case report in medicine?

Case reports in medicine are fundamentally individual patient stories generally describing unique or unexpected findings in terms of disease or treatment. Anecdotally based, they are considered to be less rigorous an evidentiary base than other types of research.

How do you document adverse events in clinical trials?

If a medication was given for an adverse event, document the drug, start/stop dates, and response The investigator should ensure the accuracy, completeness, legibility, and timeliness of the CRF data. This can be accomplished and documented either electronically or by paper.

What is Citrix Gateway?

Citrix Access Gateway allows access to almost all VA internal resources. VA uses a single website that can be used to access VA Citrix farms from internal VA computers or from non-VA internet connected endpoints. Two factor authentication is required to access VA resources remotely (VA smartcard and/or OTP/Mobile Pass).

How often do you log in to Citrix CPRS?

You must log in every 90 days or you will have to re-apply.

What is the VA Enterprise Service Desk number?

This method is only valid between VA user accounts. For further assistance or problems with this you can contact the VA’s Enterprise Service Desk at (855) 673-4357 or Teletypewriter (TTY) Relay Number: (844) 224-6186.

CRF Completion

The CRF must be completed by authorized site personnel, as documented on the delegation of authority log. Ensure that all CRF pages are signed and dated by the person completing the form

Verification of CRFs

The investigator should ensure the accuracy, completeness, legibility, and timeliness of the CRF data. This can be accomplished and documented either electronically or by paper. For electronic data capture, the sponsor may ask the PI to electronically sign each CRF page or multiple CRFs at defined periodic time points.

Maintenance and Storage of CRFs and Source Documentation

CRFs should be promptly completed after the data is collected. A backlog of CRF entries compromises the data integrity. You may not be able to recall the data later. Once the study is complete, CRFs should be kept either via paper copy or on a CD-ROM.

Informed Consent Form

Informed Consent Discussion

  • The researcher must conduct the informed consent discussion that is in a language that is understood by the subject. Additionally, the informed consent form must be in a language that the subject can read. The investigator, or his/her designee as documented on the delegation of authority log, must fully inform the subject of all pertinent aspects of the trial including all of the …
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Signing The Informed Consent Form

  • When the subject returns to the study site, the investigator will need to assess the subject’s understanding of the study and ask if he/she has questions. If the subject is ready to sign the ICF, he/she must personally sign and date the form. The investigator, or his/her designee, must also personally sign and date the form as the person obtaining informed consent. If a legally authoriz…
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Documentation of The Informed Consent Process

  • The informed consent process must also be documented in the research or medical record. A brief note should describe the date and time the informed consent discussion began, whether the subject was given time to read through the ICF and ask questions, who reviewed the ICF with the subject, the date and time the consent was signed, and that a copy w...
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Informed Consent Form Revisions and Reconsent

  • Whenever there are substantive changes to the protocol or when important new information becomes available you will need to revise the ICF. Often times the sponsor will send ICF changes to the study team with a protocol change or new safety information. If the changes are being initiated by the investigator rather than sponsor, the PI must first seek the sponsor’s approval fo…
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