Make a data collection form or spreadsheet listing the data to be recorded. On this form or spreadsheet include no identifiers, links to identifiers, or coded identifiers. Pick an identifier from the list created in step 1 and confirm the subject meets inclusion/exclusion criteria If the subject does not meet inclusion/exclusion criteria, mark the identifier on the list created in step 1 as completed. If the subject meets inclusion/exclusion criteria, record the d ata on the form or spreadsheet created in step 2, and mark the identifier on the list created in step 1 as completed. Repeat steps 3 and 4 until all subject records have been reviewed. At no time is the information recorded on the form or spreadsheet created in step 2 in such a manner that subjects can be identified directly or through links to identifiers. If you need to retain temporary identifiers, codes, or links between the and the data being recorded, describe this. subject’s identity Describe how the data will be analyzed. Privacy & Confidentiality Describe whether the study will use or disclose subjects’ Protected Health Information (PHI). If the study uses or discloses PHI for a chart review, the PI must justify a waiver of HIPAA authorization. The criteria for a waiver of HIPAA authorization can be found in the HIPAA “WORKSHEET: Waiver of Authorization (HRP-428).” Describe the steps that will be taken to secure the data (e.g., training, authorization of access, password protection, encryption, physical controls, and separation of identifiers and data). Risks to Subjects List the reasonably foreseeable risks that are related to a subject’s chart being involved in the research (ex. The only anticipated risk to the subjects is a breach of confidentiality). Informed Consent Waiver or Alteration of the Consent Process (consent will not be obtained in the event of a chart review)
Make a data collection form or spreadsheet listing the data to be recorded. On this form or spreadsheet include no identifiers, links to identifiers, or coded identifiers. Pick an identifier from the list created in step 1 and confirm the subject meets inclusion/exclusion criteria If the subject does not meet inclusion/exclusion criteria, mark the identifier on the list created in step 1 as completed. If the subject meets inclusion/exclusion criteria, record the d ata on the form or spreadsheet created in step 2, and mark the identifier on the list created in step 1 as completed. Repeat steps 3 and 4 until all subject records have been reviewed. At no time is the information recorded on the form or spreadsheet created in step 2 in such a manner that subjects can be identified directly or through links to identifiers. If you need to retain temporary identifiers, codes, or links between the subject’s identity and the data being recorded, describe this. Describe how the data will be analyzed. Privacy & Confidentiality Describe whether the study will use or disclose subjects’ Protected Health Information (PHI). If the study uses or discloses PHI for a chart review, the PI must justify a waiver of HIPAA authorization. The criteria for a waiver of HIPAA authorization can be found in the “WORKSHEET: HIPAA Waiver of Authorization (HRP-428).” Describe the steps that will be taken to secure the data (e.g., training, authorization of access, password protection, encryption, physical controls, and separation of identifiers and data). Risks to Subjects List the reasonably foreseeable risks that are related to a subject’s chart being involved in the research (ex. The only anticipated risk to the subjects is a breach of confidentiality). Informed Consent Waiver or Alteration of the Consent Process (consent will not be obtained in the event of a chart review)
503_invest_prot_temp_chart_review.docx