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Regulatory Documents/ Investigator Toolkit

Normally used for clinical trials, but may be helpful for any large-scale research to help investigators manage their research

TMP 401 Adverse Event Tracking Log

To keep track of all unanticipated problems occurring while research is active, and its reporting

TMP 402 Delegation Log

To document the investigator's delegation of certain responsibilities to study personnel in order to conduct research

TMP 403 IRB Submission Log

To document all correspondence between the study site and IRB; includes notation of important dates (e.g., approval date, expiration date)

TMP 404 Note to File Template

Written to identify a discrepancy or problem in the conduct of a research study, note the source of the identified problem, identify corrective action taken to prevent recurrance of the issue, and document that correction action has resolved the issue

TMP 405 Protocol Deviation Tracking Log

To keep track of all protocol deviations/ violations occurring while research is active, and its reporting

TMP 406 Screening and Enrollment Log

To document identification of potential participants and chronological enrollment of participants 

Model Informed Consents

For Social & Behavioral Science (SBS) Research

Research Involving Adult Participants
TMP 441 Interview
TMP 442 Intervention
TMP 443 Anonymous Survey (Online)
TMP 444 Anonymous Survey (Direct Interaction)
TMP 457 Focus Group
Research Involving Minors (under 18 years of age)
TMP 445 Parental Consent to Interview Minors
TMP 446 Assent to Interview Minor (14-17)
TMP 447 Assent to Interview Minors (7-13)
TMP 448 Oral Assent to Interview Minors (under 7)
TMP 454 Assent, Curriculum Research on Minors (14-17)
TMP 455 Parental Consent, Curriculum Research on Minors 
TMP 457 Adult Consent, Focus Groups

For Biomedical Research

TMP 460 Adult Participants
TMP 458 Parental Consent, Clinical Research on Minors
TMP 463 Assent, Genetic Study on Minors (7-13)

Other Consent Documentation

TMP 465 Deception Research, Debriefing Form
TMP 466 Adult Consent for Oral History
TMP 467 Short Form
TMP 468 Adult Consent, Future Use of Biospecimen


Other Useful Study Documentations

TMP 475 Model Recruitment Flyer
TMP 407 Endorsement Letter Template