Additional forms have been made available on the eRA System and are complementary to the initial full application process. These forms are:

Forms
Description
Download
Amendments form
 This form is used to request changes to an already approved research project, and might include changes to the research design, methods, participant population or any other aspect that could include, but are not limited to, the ethics or risk level of your study. This form should be submitted when there are changes to the research protocol due to new developments, or updates that might affect participant safety or confidentiality. 
  1. Creating review sheets on an Amendment form as the Committee Administrator
  2. Initiating the Incident and Amendment forms
  3. Initial review of an Amendment application as the Committee Administrator
  4. Initial review of an Amendment application as the Committee EXCO
Renewal form
 When research projects require an extension beyond the initial approval period, the renewal form should be submitted. This form should be initiated if the research period is taking longer than expected, or if additional time is needed to complete certain research activities.
  1. Creating review sheets on a Renewal application as the Committee Administrator
  2. Initiating a Renewal form as an applicant
  3. Initial review of a Renewal application as the Committee Administrator
  4. Initial review of a Renewal application as the Committee EXCO
Closeout report
 The Closeout report should be submitted once the research project has concluded. It allows the researcher to provide a final summary of the research study, and confirm that all ethical requirements for the study have been met during the research process. It would typically include information about how the data will be handled, any issues that arose during the course of the study, and whether the ethical standards were upheld. 
  1. Initiating a Closeout report as the applicant
Progress report
 The progress report provides a periodic update on research activities, to review whether ethical standards are being maintained during the course of the research project. The form allows the researcher to reflect any new challenges which may impact their research, and to ensure that the research protocol is being adhered to as the research study progresses. 
  1. Initiating a Progress report as the applicant
Incidents form
 The Incident form can be used to report any unexpected ethical issues or adverse events that occur during a research study. The person reporting the incident may choose to remain anonymous, but has to provide as much study detail as possible, including the name of the study as well as the name of the principal investigator. 
  1. Capturing Sub-committee feedback on the Incident form as the Committee Administrator
  2. Capturing the outcome of the reported incident by the Committee Administrator
  3. Reviewing an Incident form as the Committee Administrator