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1. Introduction  
2. Setting up Office and Research Space
2.1 What should I do before I get to UCSF?
2.2 What should I do once I arrive at UCSF?
2.3 What Research Support Services are available?
3. Obtaining Regulatory Committee Approvals
3.1 Making Sense of Regulations
3.2 What is Research Online
3.3 Working with Biologicals
3.4 Working with Chemicals
3.5 Working with Radioactive Materials
3.6 Working with Radioactive Materials in Humans
3.7 Working with Controlled Substances
3.8 Working with Animals
3.9 Involving Human Subjects in Research
3.10 Serving on Committees
3.11 Working with Affiliates
4. Finding, Obtaining, and Managing Money
4.1 Fiscal Responsibility
4.2 Pre-award: How do I find and ask for funds?
4.3 Post-award: How do I manage funding awards?
4.4 Working with Industry
4.5 Minimizing Financial Conflicts of Interest
4.6 Intellectual Property
5. Being Responsible
5.1 Ethical Conduct of Research
5.2 Authorship and Publication
5.3 Confidentiality and Privacy
5.4 Data Management: Research Records
5.5 Training in Responsible Conduct of Research
5.6 Guidelines for Lab Notebooks
6. Leaving or Transferring Funds/Specimens Out of UCSF
I. UCSF Acronyms
II. UCSF Research Links
III. Whistleblower Policies & Procedures
School of Medicine Clinical and Translational Research



5. Being Responsible

5.4 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:

•  Are the research records legible, accurate, and complete? Are they in sequence and dated? Is the researcher identified in the records?
•  Are there reasonable plans for retention, retrieval and storage of the data?
•  Have you managed the data so it can be shared if required by funding agencies?
•  Would an audit of the research records support your claims in your publications?
•  Could co-investigators confirm the accuracy of the manuscript from the laboratory or research notebooks?
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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:

•  Validity and quality of the data and manuscripts.
•   Fulfilling all departmental and University research standards, policies, and procedures.
•  Training and monitoring the performance of your students, research fellows, residents, and staff to assure that each has the knowledge, information, and skills necessary to meet these standards.
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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@itsa.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.

•   Research Record Retention & Disposition Requirements
•   Guidelines on Research Data and Reports (Dept. Neurological Surgery)
•  How to Keep a Laboratory Notebook for Patent Purposes (Office of Technology Management)
•  Office of Research Guidelines for Laboratory Notebooks
•  NIH Data Sharing Policy
•  FAQ for Quality Improvement Program
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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.

•   NIH Web Resources for Bioethics:
  •   Research Resources (humans, animals, conflict of interest, others)
  •  Other Federal Resources (agencies, genetics, human research)
•  Council on Government Relations (1996): Access to and retention of data.
•  Office of Research Integrity (ORI)
•  Food and Drug Administration (FDA):
  •  Good Laboratory Practices for nonclinical laboratory studies (GLP)
  •  Good Clinical Practices (GCP) Program
  •  GCP Guidelines
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