Submissions

Closure procedures…

Below are the procedures for amendments/modifications, which will need to be tweaked for closure.

Amendments/modifications to the study protocol or contract may require a change to the MCA and/or Calendar in Clinical Conductor.  Changes also include PI or staff and study status. 

1. PROTOCOL AMENDMENTS

1. Send an email to the following recipients: jvillasin@queens.org

with a cc: to sdelacruz@queens.org , dtani@queens.org , ltsue@queens.org and rohta@queens.org.

if the study involves a drug, cc:  ids_manamana@queens.org

2. Include the following in the Subject of the email:

• [Type of Change]: [RA Number] [Short Name of Study] [Amendment/Revision Number]
• Example: “Protocol Amendment: RA-2023-XXX STUDY A5”

3. In the email provide the following information about the study, as applicable:

• Study Title:
• Amendment/Revision Number:
• Study Status (ie Enrollment, Closed to Enrollment – Continue Visits):
• Number of Patients on study:
• Describe the changes to the MCA, Calendar and/or Contract:
• Indicate whether the amendment or revision has received IRB approval:
  • If already approved and ready to go, the revised MCA will be set as active
  • If not IRB approved, the older version will remain active until IRB approval/active status

4. Provide the following soft copy documents as attachments:

• IRB Approval Letter
• Track Change and Clean version of amended Protocol/document, or Detailed summary of changes.
• Track Change and Clean version of revised Informed Consent Form
• Revised Funding Sheet or proposed revised Contract/Budget
• Any other additional documents, as required (eg. HIPAA Authorization, Supplemental Info Sheet, etc.).

5. If changes to the MCA and calendar are required, proposed changes will be provided to the Study Coordinator within 10 business days for review, feedback and edits in the format of an excel file. Once proposed changes are aligned, then the final calendar will be provided to the Study Coordinator for final review.

6. If there are no changes to the MCA, Calendar or Contract, then the amendment will be processed in Clinical Conductor.

7. The protocol amendment will be activated upon receipt of IRB approval letter, IRB approved documents and updated CTA, budget as applicable.
8. Once the amendment is finalized and active, patients need to be transferred and new patients are to be enrolled on the most current protocol.

1. PI OR STUDY STAFF CHANGE

1. If a change to the PI or staff need to be added or removed from the study, send an email to the following recipients: jvillasin@queens.org

with a cc: to sdelacruz@queens.org , dtani@queens.org , and rohta@queens.org.

2. Include the following in the Subject of the email:

• [Type of Change]: [RA Number] [Short Name of Study] [Amendment/Revision Number]
• Example: “PI CHANGE: RA-2023-XXX CSTUDY A5” or “STAFF CHANGE: RA-2023-XXX CS0TUDY A5”

3. In the email provide the following information about the study, as applicable:

• Study Title:
• PI or Staff Change (indicate who to add or remove):

4. Provide the soft copy IRB Approval Letter for PI Change.

STUDY STATUS CHANGE

 

1. If the status of the study changes, send an email to the following recipients: jvillasin@queens.org

with a cc: to sdelacruz@queens.org , dtani@queens.org , and rohta@queens.org.

2. In the email provide the following information about the study, as applicable:

• Study Title:
• Study Status Change (eg. Closed to Enrollment – Continue Visits, Suspended, Terminated, etc):

3. For study closure, provide the soft copy of notification letter from the Sponsor or IRB.

 

QUESTIONS/CONCERNS:

Contact Jeremiah Villasin at 808-691-4645 or jvillasin@queens.org

or

Rebecca Ohta at 808-691-4106 or rohta@queens.org