Templates for Prospective Research Biomedical Applications:
Templates for Secondary Use Biomedical Applications:
To protect participant identity, identifying information must not be recorded in the data set. Identifying information must be kept separate from the data. Creating a master list and a data collection tool, on separate pages/documents is one way to accomplish this. This is an example:
Hospital Chart Number
Data Collection Tool:
Date of Dx
Admitting blood glucose level
Discharge blood glucose level
The master list should include one identifier (e.g., medical record number, health services number) and a unique non-identifying participant ID. The data collection tool should include the same participant ID and the data elements you plan to extract from the participant’s chart. The data collection tool should not contain any names or other identifiers with the exception of the study identifier. The master list is the link back to the source document.
Postal code and date of birth are indirect identifiers, as when either is combined with other data points, it increases the likelihood that the participant could be re-identified. If you need these identifiers for your project, you must provide justification for their inclusion. You should only collect that which is necessary to address your research questions.
Submit your template data collection tool and master list along with your application and provide a statement confirming the two documents will be stored separate and apart from each other.