THE OFFICE OF RESEARCH
RESEARCH INVESTIGATOR HANDBOOK
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
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:
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.
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?
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.
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.
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
Who should I contact if I am notified that I will be audited
by an outside agency?
should I contact if I am notified that I will be audited by an
As soon as possible, contact UCSF’s Audit
and Management Services at (415) 476-3851 or by email at email@example.com.
They will work with you to determine what you need to do. You
should also inform you Department’s Chair of the pending
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
Policies and Procedures
UCSF: This is a partial list of guidelines
available at UCSF. Check with your Department as they may have
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.