THE OFFICE OF RESEARCH

NEW INVESTIGATORS: A QUICK GUIDE TO STARTING YOUR RESEARCH AT UCSF

Table of Contents

Being Responsible - Other Topics:
| Ethical Conduct of Research | Authorship and Publication | Confidentiality and Privacy |

DATA MANAGEMENT: RESEARCH RECORDS

• What are research records?
• What points should I consider when managing my data?
• What am I responsible for?
• Could my research records be audited?
• Who should I contact if I am notified that I will be audited by an outside agency?
• Relevant Policies and Procedures

What are research records?

Typically, research records refer to any type of records or materials that document your research effort for laboratory (“bench”) research, animal research, and clinical trial research. These can be electronic or hard copy as in various forms of logs, notebooks, correspondence, libraries, videos, computer databases or records, audio or digital records, or even the actual products of experiments such as gels.

In addition to maintaining accurate and complete research records for data analysis, all records relating to the conduct of the project are important including those that document the management of the research funds and the intellectual property.

Although not an inclusive list, research records typically include:

•	Laboratory research: lab notes, notebooks, computer databases, microscopic slides, gels, images, photos, videos, laboratory equipment printouts, and records of statistical and other data analysis.
•	Animal research: protocol binders with IACUC-approved protocols with all approved modifications, animal health records, surgical or treatment records, breeding records, drug records, research data files.
•	Clinical trials: regulatory binders which include CHR approvals, protocols, informed consent documents, monitoring reports, adverse event reports, and other documents pertaining to sponsors, drugs and devices. Other clinical records can include records for research data, data analysis, audio and video tapes of subjects, images of subjects and any other type of record that can identify persons that data were collected from.
•	Funding: records and correspondence relating to the grant financial records, purchasing records, scope of work, budgets, and service records.
•	All correspondence with granting agencies, institutions, and collaborators.

What points should I consider when managing my data?

The integrity of your data is dependent upon having and using a system of data management. When determining how data will be collected, recorded, and stored, you should consider the following:

Your research records are the source documents for verification of your research by governmental or University investigations and audits. Clear, permanent records of research are crucial for clarifying any challenges to your data authenticity, authorship and intellectual property.

What am I responsible for?

As the PI, you should observe sound practices for the maintenance, oversight, and storage of data as you have the final responsibility for the following:

Could my research records be audited?

Your research records may be audited by 1) University officials, 2) your department, as well as by 3) outside governmental agencies, such as NIH, FDA, or the USDA.

There are various reasons research records are audited including random audits for quality assurance as well as for-cause audits for financial, scientific, or for court actions to resolve disputes or allegations of scientific misconduct.

UCSF guidance on audits and investigations is included in the Faculty Handbook, Faculty Guide to Success and other documents located on the website of the Office Academic Personnel and on the Committee for Human Subjects (CHR) website for the Quality Improvement Program.

Who should I contact if I am notified that I will be audited by an outside agency?

Who should I contact if I am notified that I will be audited by an outside agency?

As soon as possible, contact UCSF’s Audit and Management Services at (415) 476-3851 or by email at audit@audit.ucsf.edu. They will work with you to determine what you need to do. You should also inform you Department’s Chair of the pending audit.

Even if you have no advance notice, for example the FDA is literally knocking on your door, contact the Audit and Management Services immediately. In the case of FDA audit, you must also contact the CHR.

Relevant Policies and Procedures

UCSF: This is a partial list of guidelines available at UCSF. Check with your Department as they may have further requirements.

Good Research Practices: Additional web resources for good data practices address a variety of data management issues that include general research practices, data retention and records storage, data ownership, and data sharing.

Data Sharing: As of October 1, 2003, certain categories of NIH research grants must include Data Sharing Plans. Additional internet resources for data sharing will be added as they become available.