Basic Guidelines for New Investigators

Module 1

Project Feasibility, Protocol, Consent Form and Case Report Form Development

Principal Investigator (PI)

The title “principal investigator” is normally available only to full-time faculty, or full-time staff positions enjoying similar rights and privileges. The principal investigator is the person who:

  • prepares a detailed description of the research project and costs;
  • assumes full responsibility for the scientific and intellectual direction of the project;
  • supervises the training of all individuals involved in the research project;
  • submits technical, progress, intervention, financial and final reports;
  • responsible for ensuring the project complies with federal and state laws and regulations including completion of an annual conflict of interest disclosures;
  • assumes financial management of the project;
  • complies with terms and conditions of the award/contract; and
  • adheres to University policies, including completion of an Employee Intellectual Property Agreement as necessary.

Project Feasibility

Whether an investigator is developing a research project (investigator initiated) or considering a research project provided from an outside sponsor (federal government, foundation, pharmaceutical company) there are factors that should be considered before undertaking the project.

  • Are there sufficient numbers of subjects?
  • Do you have access to the subject population?
  • Is the project financially viable?
  • Do you have the space to conduct the study?
  • Do you have support staff? Biostatistician? A clinical study coordinator?
  • Will you have time to adequately train and oversee support staff?

Protocol Development

Investigator Initiated Studies

Investigators considering writing a research protocol must include specific information regarding the study. This is necessary to ensure that there is adequate information for the various oversight committees to review and approve the study. The protocol describes how the project will be conducted. It is the central guidance document for the study and study personnel.

The basic information required is presented below. More detailed information can be found at

  • Purpose of the Study and Background
  • Characteristics of Research Population

-# Of Subjects

-Gender

-Age

-Racial and Ethnic Origin

-Inclusion Criteria

-Exclusion Criteria

-Vulnerable Subjects

  • Methods and Procedures

-Schema

-Research Design

-Procedures/ Tests/ Interventions

-Statistical Considerations

-Adverse Event Reporting

-Data Analysis and Data Monitoring

-Data Storage and Confidentiality

  • Risk Benefit Assessment

-Risk Category

-Potential Risk

-Protection against Risk

-Potential benefits to Subjects

-Alternatives to Participation

  • Subject Identification, Recruitment and Consent/Assent

-Method of Subject Identification and Recruitment

-Process of Consent

-Subject Capacity

-Subject/Representative Comprehension

-Consent Forms

-Documentation of Consent

-Costs to the subject

-Payments for Participation

The investigator may want to contact the department of Biostatistics for assistance in design, management and analysis of research studies. Investigators requesting Biostatistics participation in research projects are asked to contact the Department well in advance of any grant deadline.

The FDA’s Advisory Committees issue clinical guidelines by therapeutic grouping. These guidelines contain specific information on recommendations for the design and conduct of clinical trials. Investigators will find these guidelines useful when designing an investigator initiated clinical trial. The guidelines can be found on the Center for Drug Evaluation and Research web site by searching the Guidances link.

Protocol Developed by Sponsor

In most cases, protocols provided by an outside sponsor are final and contain all the information required by the reviewing committees. There are some instances where the investigator’s input into the protocol is sought before the protocol is finalized.

Consent Form Development

The informed consent process is one of the basic ethical obligations for investigators. Part of the informed consent process is the consent form itself. In general, sponsors provide a template consent form with the protocol. These consent forms need to be modified to meet University required standard wording for compensation for injury. For industry sponsored studies . For non-industry-sponsored studies

Guidance for HIPAA Authorization,see

Each research study involving human subjects is unique, the federal regulations and the University require that all consent forms contain the following information elements:

  • Introduction (with a statement that this is a research study)
  • Purpose of study (should agree with protocol)
  • Description of procedures that will be encountered during the research (all procedures should be listed, specifically those that are experimental)
  • Duration of subject involvement
  • Risks and discomforts of participation
  • Benefits of participation
  • Confidentiality of records statement
  • Contact persons (up to three different people need to be named)
  • Statement of voluntary participation
  • Statement that subjects will receive a copy of the consent form

The federal regulations and the University also require several other element of information be included if they apply to the study and are important for subjects to know. These include:

  • Compensation for injury statement (for greater than minimal risk studies)
  • Alternatives (i.e., other courses of action, if any)
  • Unforeseen risks statement (if applicable, i.e., phase 1 drug trials)
  • Reasons for involuntary termination of participation (if applicable)
  • Additional Costs to participate (if any)
  • Consequences for withdrawal (adverse health/welfare effects, if any)
  • New findings statement (to be provided if relevant to continuing consent)
  • Numbers of subjects (if it may impact the decision to participate)
  • Payments to subjects (incentives and/or expense reimbursements, if any)
  • Impact on the quality of life (e.g., chemotherapy trials)
  • Funding statement for sponsored studies

Further information regarding the informed consent form templates can be found at

Case Report Form Development

For industry-sponsored studies, Case Report Forms (CRFs) are used to capture all data required by the protocol on each subject. The sponsor usually provides the CRFs to be used in the study. The sponsor may use paper or electronic (Remote Data Entry) CRFs. The investigator will need space for the remote data entry equipment (e.g., dedicated fax machine, computer) and IT support.

For investigator-initiated studies, the investigator will need to develop a data collection form like the CRFs. The department of Biostatistics can assist with the CRF development

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