Completing the Annual Principal Investigator Worksheet
This Quickguide provides instructions for completing the Annual Principal Investigator Worksheet.
BEFORE YOU BEGIN
- Consider printing a copy of the Worksheet by clicking here to use as reference as you complete the Worksheet in IRBManager.
- The Worksheet should be completed by the Principal Investigator (PI) or PI’s designee.
- You will use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to make any changes to the auto-populated information relating to the person submitting and the PI. For more information, go to Updating Your CIRB Person Roster.
- If you are a Consortia site, go to Navigating the CIRB as a Consortia Site for information on how processes vary for you.
The PI or designee should answer all the questions on the Annual Principal Investigator Worksheet found in IRBManager.
The first time you complete the Worksheet, check the box indicating that this is a first submission. You’ll indicate revised submission in subsequent Worksheets submitted after initial approval.
COMPLETE THE SIGNATORY INSTITUTION INFORMATION QUESTIONS
- Question 1: This field indicates the PI associated with this Worksheet. The email address entered must be the one associated with the PI in RUMS.
- Question 2: Select the institution associated with this submission. In most cases, only one is available in the dropdown selection for the PI. If a PI is associated with more than one institution, be sure to select the one associated with this submission.
COMPLETE THE RESEARCH STAFF QUESTIONS
- Question 3: Enter the number of sub-investigators who will be enrolling participants in the studies opened by this PI.
- Question 4: Enter the number of research nurses or Clinical Research Associates who will be supporting the PI in the studies opened by this PI with the CIRB.
- Question 5: Assess the financial conflict of interest. PIs are responsible for reporting any financial conflict of interest for themselves and their research team to the CIRB with an appropriate management plan.
COMPLETE THE PRINCIPAL INVESTIGATOR RESOURCES QUESTIONS
- Question 6: These questions address all research being overseen by the PI. For this question, enter the number of all research studies open by the PI. This includes both investigator-initiated trials and those sponsored by pharmaceutical companies. Question 6a auto-populates the listing of open studies associated with a particular PI.
- Question 7: Enter the number of study participants currently receiving treatment on all studies the PI has opened. This number should not include study participants who are in long-term follow-up. It should pertain only to the participants actively receiving study intervention.
COMPLETE THE RECRUITMENT QUESTIONS
- Question 8: Indicate all the different recruitment methods used by this PI.
- Question 9: For CIRB-studies, indicate how study participants are being identified.
NOTE: Any recruitment materials developed locally must be submitted to the CIRB for approval prior to use.
COMPLETE THE COMPENSATION TO STUDY PARTICIPANTS QUESTION
- Question 10: Although study participants are not likely to receive compensation for participation in these trials, indicate whether there are any local forms of compensation provided. Examples of compensation include free parking or lunch vouchers.
COMPLETE THE INFORMED CONSENT PROCESS QUESTIONS
- Question 11: The discussion with the potential study participant should take place in a private location. Describe the private location where the potential study participant is approached to discuss the study.
- Question 12: Per FDA guidance, if a PI delegates the responsibility of the consent interview, then the individuals should be qualified by education, training, and experience to perform this activity. Each person permitted to obtain consent should be listed by role.
- Question 13: Describe how the consent process continues after the initial discussion and the amount of time the study participant has to make a decision. Potential study participants should not feel pressured to sign the consent form.
- Question 14: Indicate the person’s name and the role for each individual who is available to answer the potential study participant’s questions.
- Question 15: Indicate how the assessment of an individual’s competence is made by the PI or research team. It is important that the individual who provides consent is assessed to determine whether there is any impairment; in other words, is the individual able to make a fully informed decision based on the information provided.
- Question 16: If an individual does not speak English, provide the process for determining whether or not to approach the individual about participating in a study and how the consent process will be conducted with that individual.
- Question 17: Consent should always be obtained by the potential study participant. Some studies allow a legally authorized representative (LAR) of an adult to consent for them or a parent of a child to consent. If your PI will enroll impaired adults or children, indicate the names of the individuals who will be able to consent. The answer to this question affects the information needed for Questions 19, 26, and 27.
- Question 18: Some PIs have a patient population who do not speak English. If the PI enrolls study participants who do not speak English, indicate those languages that are used frequently enough to require translated consent forms. Provide the process for obtaining those translations.
- Question 19: If Question 17 indicated that the PI will allow legally authorized representatives and parents of potential pediatric study participants, describe how assent is obtained from the adult or minor study participant.
NOTE: The CIRB makes a determination regarding the requirement for assent and the age determination. Institutions enrolling children must obtain assent from any child in the age range determined by the CIRB. Local policy determines the documentation of the assent and should be described here. If a child in the age range determined by the CIRB cannot provide assent, an Assent Waiver must be requested from the CIRB and obtained prior to enrollment of the child.
- Question 20: Study participants need a pathway to provide feedback about their experience and express concerns. Describe the pathway the PI provides to study participants and how answers to feedback and concerns are provided.
COMPLETE THE PHARMACY INFORMATION QUESTIONS
- Question 21: Some study drug/agents are managed by a pharmacist, while some are managed by the study team. Indicate who is responsible for managing study drug/agents for the PI.
- Question 22: Describe how pharmacists who manage the drug/agents receive a copy of the protocol.
COMPLETE THE MEASURES TO PROTECT CONFIDENTIALITY QUESTION
Question 23: Select all measures used by the PI and research team to protect the confidentiality of study participants.
COMPLETE THE MEASURES TO PROTECT PRIVACY QUESTION
Question 24: Select all measures used by the PI and research team to protect the confidentiality of study participants.
COMPLETE THE EMERGENCY RESOURCE QUESTION
- Question 25: Select all resources available to the PI and research team to treat any emergencies resulting from study-related procedures.
COMPLETE THE USE OF LEGALLY AUTHORIZED REPRESENTATIVE (LAR) QUESTIONS
- Question 26: If Question 17 indicates that a LAR could provide consent, answer this question “Yes.”
NOTE: If a LAR is not selected for Question 17 and this question is answered “No,” a study participant cannot be enrolled on a study until this Worksheet is updated to revise these questions.
- Question 27: If Question 26 is answered “Yes,” provide a description of who may serve as a LAR or attach the appropriate Standard Operating Procedures (SOPs).
- Question 28: Indicate how the PI or research team evaluates the individual providing consent. The Individual must be assessed to determine they are not impaired and can make the decision about participation based on the information provided.
COMPLETE VULNERABLE POPULATIONS QUESTIONS
- Question 29: The CIRB needs to know whether there are vulnerable populations that could be enrolled into studies and any associated protections. When you check the box for any vulnerable populations, additional questions with possible protections will appear.
Questions 30 to 32 relate to additional confirmations that need to be made when a PI intends to enroll pregnant women in a study.
NOTE: Even though it is unlikely that the PI will enroll a pregnant woman, there are certain confirmations that PIs must make if a participant becomes pregnant. In this case, questions 30 to 32 must be answered “Yes.”
- Questions 30: Confirm by selecting “Yes,” that no inducements will be made to terminate a pregnancy.
- Question 31: Confirm by selecting “Yes,” that the research team will have no part in decisions related to the timing, method, or procedures used to terminate the pregnancy.
- Question 32: Confirm by selecting “Yes,” that the research team will have no part in determining the viability of a neonate.
- Question 33: In some cases, there are distinct local context considerations for the PI that are not captured by any of the other questions. This space can be used to outline those special considerations.