Data management {19}
FIRE
We use a digital data capture system and collect data on password-protected laptop computers. Specifically, this multi-user system is registered with CUIMC IT. Data is transferred, encrypted, backed up, and transferred to the data manager who review the forms daily for completeness.Data is transferred via a firewall-protected, secure, electronic file-transfer to computer server space dedicated to the proposed study and protected with firewall and encryption technologies. Only Dr. Hernández, the Project PI, has master access to this server and she is required to authenticate herself via password each time the data is accessed.Because this study is funded by the National Institutes of Health (NIH), the study is automatically issued a federal Certificate of Confidentiality. It is possible that participants will disclose information during their participation in the study and/or interviews and focus groups that indicates their involvement in illegal activities or indicates illegal activities by others. A Certificate of Confidentiality is one further means of ensuring that this information is kept confidential. Should participants disclose information in the middle of an interview that clearly indicates that they or those around them are in imminent danger, the interview will be suspended and 9-1-1 will be contacted.Personally identifiable information (PII) is collected and entered into an electronic database for each study participant. This PII data is necessary to conduct the trial and include the following: name; street address, city, county, and zip code; telephone numbers; and possibly electronic mail addresses. All data is specifically used for the purposes of the proposed research. No PII is disclosed to anyone who is outside of the proposed research team and all PII will be destroyed when the study is concluded. We institute strict precautions and security procedures to maintain data integrity and confidentiality:All data is stored on a centralized computer server at the Columbia University Mailman School of Public Health. This server is dedicated to the proposed study and is protected with up-to-date “fire wall” electronic security technology.Only Dr. Hernández, the Project PI, and the Project Coordinator have master access to this server and the data.Computer administrators, co-investigators, a project manager, project coordinators, and laboratory staff are only granted data access at the discretion of the Principal Investigator. Furthermore, this access is only granted as needed for finite periods of time throughout the study.On a regular daily basis, laboratory staff destroy any “portable” data (including both electronic and paper copies) that are transferred from external data sources to the university computer server.Once all records are linked and compiled into a single database, any and all PII identifiers will be destroyed.The PI and the project coordinator are responsible for providing and documenting appropriate user access to the study database and preventing against major sources of data security problems: unauthorized internal access to data, external access to data, and malicious intent to destroy data and systems. This user access ensures that only appropriate and authorized personnel are able to view, access, and modify trial data.Modifications to data will be performed in a manner that documents data modification, user access associated with modification, data associated with modification, and values prior to modification. The PI and the project coordinator will also be responsible for optimizing database performance, reliability, and backup of data. External, unauthorized access to data is prevented through cooperative efforts of the PI, the project manager, and network and systems administrators. Highly successful measures are employed through network firewall technologies to prevent unauthorized external access to data repositories.