Summaries should always describe the purpose and status of the study.
- Purpose of the study – This can be brief – typically one or two lines. If it is a statistical data analysis center (SDAC) study or treatment use application, indicate this to distinguish it from a typical research study.
Where to find this information:- Study title
- In non-protocol based applications, Q1 on the Research Design page of the main application
- In the protocol within the main application
- In the consent form (plain language definition) uploaded to the main study workspace and within the main application
Examples:- The purpose of the study is to determine the safety and efficacy of neoadjuvant dasatinib in subjects with triple negative breast cancer.
- (SDAC application) This is a statistical data analysis center/reading center application; UW is analyzing samples collected at other sites. The purpose of the overarching study is to evaluate the safety and efficacy of cabozantinib with or without radium-223 dichloride in evaluating the safety and efficacy of cabozantinib with or without radium-223 dichloride in metastatic renal cell carcinoma patients with bone metastases.
- (Treatment use application) This is a treatment use application for the one-time use of clofazimine to treat mycobacterium abscessus and avium infection of the lungs in one patient.
- Study status – Indicate if enrollment is ongoing or closed. If enrollment is closed, indicate what study activities remain.
Where to find this information:- Within the CR form
Examples:- Enrollment is ongoing.
- Enrollment is closed. Study treatment, data collection and data analysis are ongoing.
- (for SDACs) The overarching study is open to enrollment.
- (for SDACs) Study data is received for 3 separate studies – one study is complete and two of the overarching studies are still open to enrollment.
- (for treatment use applications) Patient is doing well and continues on treatment. Provider plans to continue treatment as long as patient continues to benefit.
- (for treatment use applications) The patient received 4 cycles under the application and continues to be monitored.
- Within the CR form
*If present, other issues should also be summarized. Below are the most common other noteworthy items. This is not an exhaustive list. Other noteworthy items will always be described in the pre-review checklist.
- *Unusual enrollment or withdrawal information – describe issue.
Where to find this information:- Issues will be described in the pre-review checklist
- Details will be within the CR form
Examples:- At CR007 the study team reported that 17 participants had been withdrawn by the study team in total. After a thorough review of OnCore, with this CR the study team has updated their withdrawal numbers to include 6 withdrawals that were not previously reported for a total of 23 participants. None of these withdrawals appear problematic. It appears no further action is needed.
- *Submission of Data Safety and Monitoring Committee or Board (DSMC, DSMB) reports – indicate if present and the committee/board’s recommendation.
Where to find this information:- Pre-review checklist will note if these were submitted. As applicable, any issues will also be noted.
- Report will be within the CR form
Examples:- There were no concerns noted in the DSMB report.
- DSMB reports recommend study continuation.
- *Submission of Revised Investigator Brochures (IDBs) or package inserts – indicate if submitted and if you agree with the study team’s assessment that no changes are needed. Summarize any issues.
Where to find this information:- Pre-review checklist will note if these were submitted. As applicable, any issues will also be noted.
- IDBs and package inserts, as well as the completed log, will be within the CR form
Examples:- Revised package inserts were submitted.
- A revised IDB for Nivolumab was submitted.
- *Concurrent IRB review of another follow-on submissiontype (change of protocol or reportable event) – indicate if present and if it affects the review of the CR.
Where to find this information:- Pre-review checklist will note the concurrent review and briefly describe the other follow-on submission
- Details will be in the other follow-on submission form
Examples:- There is a change of protocol under review for this study to add a fasting option and increase the total time for a single visit. These changes would only be applied to new projects. The change does not appear to impact review of this continuing review.
- There is currently an unanticipated problem reportable event under review. The event involved a subject leaving the study visit location in between study activities with an IV in place; the subject did not want to have the IV redone and preferred to keep it in place while waiting for the next activity but did not want to wait at the Waisman Center. As a single isolated event, this event does not appear to impact this continuing review. It appears these reviews can remain separate, and no further action is needed on the continuing review regarding the RE.
- *Study expiration – indicate if study is expired and briefly describe the issue.
Where to find this information:- Pre-review checklist will describe issue
- Details will be within the CR form
Example:- This study is currently expired. The CR was submitted late due to a misunderstanding of the IRB’s submission guidance. The study team confirmed no activities would occur during expiration. The proposed corrective action appears adequate to address the cause of this expiration and prevent future expiration. Suggest this is not serious noncompliance, and as this is the first expiration on the study, this is not continuing noncompliance. Suggest no further action is necessary.
- *Shorter Review Period – indicate if the study is on a shorter review period (less than 12 months)
Where to find this information:- Pre-review checklist will describe issue
Example:- This study was previously moved to a 6-month review period due to the study risk and history of reportable events.
- Pre-review checklist will describe issue