Protocol Title
Protocol Title
Principal Investigator’s name and address
Some place the Sub-Investigators and their affiliations here:
John/Jane Doe, Ph.D., Associate Professor
Department of Psychology
Vanderbilt University
Table of Contents:
Study Schema
1. Background
2. Rationale and Specific Aims
3. Inclusion/Exclusion Criteria
4. Enrollment/Randomization
5. Study Procedures
6. Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or Others
7. Study Withdrawal/Discontinuation
8. Statistical Considerations
9. Privacy/Confidentiality Issues
10. Follow-up and Record Retention
1. Background
This is the history of the problem/disease, and why it is important to study this particular problem/disease. Discuss how this affects the target population, how many are affected…
2. Rationale and Specific Aims
This is the “why” this study is important to conduct and what you plan to do.
3. Inclusion/Exclusion Criteria
List the criteria:
• Bullet or number each criteria for easy identification.
4. Enrollment/Randomization
List the process for randomization and/or registration; list the address, phone number or website where the registration will take place.
5. Study Procedures
If multiple experiments are to be done, describe each separately. Include all interventions, experimental manipulations, data collection procedures, and measurements.
List the days and time frame of the study. Begin with screening procedures if applicable. A table format may be useful to outline what will happen, when it will occur, and who will be responsible.
Provide a description of what the participants will experience. For example, a description of the instructions that will be given to the participants, activities in which they will engage, the length and timing of involvement, and the circumstances under which they will provide data (e.g., phone calls, spending time in an uncomfortable position, group assessments, one-on-one interview, videotaping, audio taping, etc.)
6. Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or Others
List the process for the reporting of adverse events or unanticipated problems involving risk to participants or others. Indicate where and how to submit AEs/unanticipated problems and the time frame in which to submit. List the regulatory authorities and their contact information for reporting, if needed.
7. Study Withdrawal/Discontinuation
List the process for the participant to withdraw himself or herself from the study. List the process for being withdrawn from the study and the indications for withdrawal.
8. Statistical Considerations
Describe the statistical power of the study, the confidence intervals and the method for analysis. Describe any possible deviations and their statistical impact.
9. Privacy/Confidentiality Issues
Discuss the methods for ensuring participant privacy, and the methods for protecting privacy and confidentiality.
10. Follow-up and Record Retention
List the duration of the study. List the duration of record retention and the method for destruction or the possibility of indefinite archiving of information.
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