CHART REVIEW PROTOCOL TEMPLATE

version February 2025

Include version number and/or date

Name, credentials, department

Principal investigator or knowledgeable designee

Include institutions and departments

The date range (start to end of collection) is required for retrospective chart review.

Please, be specific and consider the following:

•    How are the records selected?

•    Can you narrow the scope by tapering groups by dates, diagnosis, procedures, etc. rather than requesting access to all records?

a) Could a deidentified dataset work?

b) Could a limited dataset (with a data sharing agreement) work?

Target population inclusion/exclusion criteria with justifications:

•    Describe and include rationale for the specific population exclusions.

•    Vulnerable Populations, if any

o    If the research involves individuals who are vulnerable to coercion or undue influence, state this.

o    Note whether the dataset will include data from minors, employees, cognitively impaired individuals, or other vulnerable groups.

A summary of the primary hypothesis, purpose, scholarly rationale, and prior literature. Describe the relevant prior experience and gaps in current knowledge. Describe any relevant preliminary data. Provide the scientific or scholarly background for, the rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge.

Describe procedures for medical record data collection. Address what data will be collected and how will the data be obtained. Describe where and how long the data will be stored and who will have access to that data.

Describe the data analysis plan, including any statistical procedures or power analysis (may include the minimum number of charts needed).

Describe the steps that will be taken to secure the data (e.g., password protection, encryption, certificates of confidentiality, Data Use Agreements, etc…)

Describe how data will be handled study-wide (if multisite):

•    What identifiers will be included in that data?

•    Where and how will the data be stored?

•    How long will the data be stored?

•    Who will have access to the data?

•    Who is responsible for the receipt or transmission of the data?

•    How will data be transported?

Include the risk of breach of confidentiality if any identifiers remain on the data/samples. Do not state that there are no risks.

Include benefits to future subjects or science, if any. Enter 'N/A' if applicable.

1) If you are requesting a waiver of informed consent for this research please complete and attach to this request the form found at https://app.smartsheet.com/b/form/73999bcc409548efa5f2c58b941eda56

2) If your study does not meet the criteria for waiver of informed consent (more likely for prospective chart reviews), explain how and when consent will be obtained.

1) If you are recording identifiers from subjects who are still living, and it is not practicable to obtain their HIPAA authorization for your study, state that you are requesting a HIPAA waiver and complete and attach to this request the form found at https://app.smartsheet.com/b/form/8da23b9655264d788af673d204409d44

OR

2) List the specific HIPAA identifiers you will record in your research files.

Outline the plan to protect the privacy of subjects and confidentiality of data. The plan needs to answer the following questions:

•    What identifiers will be kept with the data?

•    If codes, where will the key linking the codes to identifiers be kept? Will other parties help create and/or host the database? How will data be securely stored?

•    Will other parties help with statistical analysis, and if so, will identifiers be stripped off first?

•    What are plans for protecting the data or disposing of it once the study is completed?

1) Select the print option, save the form, as a PDF, then include the form with the materials for submission to ORS@piedmont.org or to be uploaded into IRBNet.

2) Click the 'Submit' button.