Overview Project Management

• Scope and Feasibility of Your Project
• Staff Hiring, Orientation, and Training
• Regulatory Issues
• Data Collection and Maintenance
• Resources and Facilities
• Subject Recruitment and Ethical Considerations
• Research Documentation

Data Collection and Record-Keeping Research Budgeting and Tracking Expenses Staffing the Research Project Research Regulatory Issues Anticipating Publication of Results Resources by Research Category

“We can lick gravity,” it has been said, “but sometimes the paperwork is overwhelming.” However, when it comes to research documentation—the record of procedures, approvals, correspondence, and various other background files related to a study—the paperwork is important, and establishing good procedures from the outset of the project for maintaining essential documents can prove to be invaluable. Here are some of the fundamental points to consider:

Are standard operating procedures for your study clearly documented, including procedures for the following?

Collecting and managing data
Amending the research protocol

Obtaining informed consent from research subjects, if

applicable (For information about informed consent, see

Ethical Considerations for Clinical Research.)

Retaining research documents
Monitoring quality assurance
Research procedures particular to the protocol

 

Are the following documents on file in a readily accessible location?

A history of the study from conception to completion
All current documents related to local and federal regulatory

agencies (IRB, IACUC, FDA, etc.)

A copy of the study protocol, including all required approval

letters, renewals, terminations, and all IRB-approved

versions of the informed consent

CVs of all investigators involved in the study
Medical/professional licenses of all investigators
Laboratory certifications and normal ranges
Staff training documentation
Protocol deviation records
Correspondence with the project sponsor and regulatory

agencies

Documentation of adverse events
A blank copy of the data collection form

(Note: Documents available through OSIRIS need not be included in the regulations file.)

Do you know what help with any of these issues is available from CTSI and how to access that help?

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