16. Who has to provide a CV (Resume)? The site principal investigator and any site subinvestigator must provide a signed and dated CV. Please send it to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.
FAQ
Download FAQ as Word document
1. How can I get through all this paperwork in the minimum amount of time?
Simply call Matt Elrod at 202-877-1359. Matt is the study's IRB coordinator. He will step you through the paperwork. With Matt on the telephone, you can complete these forms in about 20 minutes. If you still want to do this by yourself, note the questions that follow.2. I have already completed HIPAA training for my facility. Do I have to complete additional HIPAA training to obtain IRB Approval?
Yes. There are HIPAA issues specific to research. All IRBs typically require this training. You can obtain this training on-line by going to the website mentioned in Question 17.
4. Who is the principal investigator?
Gerben DeJong, PhD is the principal investigator (PI) for the whole study. However, each site needs to designate a local person who will function as the site's PI in the eyes of the IRB. IRB approvals are site-specific. There must be a person on site at each facility who is responsible for overseeing the study.5. Who is the sponsor?
The sponsor is not the funder, as the term is commonly used. In this context, sponsor means the "intellectual" sponsor, i.e., the lead person (G DeJong) who takes the responsibility for the proper conduct of the study.6. Who is/are the subinvestigator(s)?
The lead person at the local site would be a subinvestigator, as we usually use the term. In the eyes of the MedStar IRB, this is not the case. Instead, the MedStar IRB asks each site to designate one subinvestigator who the Project Team and the IRB can turn to when the local site PI is not available or is no longer be with the study. Think of the subinvestigator as a back-up to the local site PI. This person can be the lead PT, OT, RN, or MD.
7. How will my site receive IRB approval?
Please complete forms 1-8 that are listed on the JOINTS website (http://www.jointsstudy.net/IRB_MRI.php). For details on how to complete each form, please see the FAQs related to the form you are completing. Once the forms are complete, please send to:
Matt Elrod, PT, MEd
National Rehabilitation Hospital Research
102 Irving St NW
Washington DC 20010.
8. How do I complete the "Institutional Investigator Agreement" document?
To complete the form you will need to add the name of the person who will serve as the principal investigator at your site and his or her contact information. Once the "Institutional Investigator Agreement" form is complete please send it along with the other forms to Matt Elrod at the address indicated above. 9. How do I complete the "Cover memo" document?
To complete the document you will need to follow the directions below:
A1)IRB Project #. Do not insert an "IRB Project number." This will be provided at a later time by Medstar Research Institute.
A2) Date of Submission. Type in the date that you are completing the document.
A4) Principal Investigator. Type in the name of the person who will serve as the site's PI. This must be a person who is on site at your facility and is overseeing the study at your site.
A4a) Contact number. Type in the phone number of the PI for your site.
A4b) E-mail address. Type in the email address of the PI for your site.
A5) Clinic Coordinator. Type in the name of the person who will help with the paperwork and day-to-day operation of the study. In most cases, this is the same person as the principal investigator. If this is the case at your site, please type in "N/A".
A6) Mailing Address. Type in the mailing address of the PI for your site.
E) Type in the name of the person who completed the form.
Once the document is complete, please return to Matt Elrod at the address above (in answer to Question 7).
10. How do I complete the "Form 2" document?
To complete the document you will need to follow the directions below:
A1a) Research location. Leave the "Other specify" choice selected. Type in the name of your facility.
A2a-k) Principal Investigator. Type in the name of the person who will serve as the site's PI. This must be a person who is on site at the facility and is overseeing the study. Type in additional information requested. If items "g" or "i" do not apply please type in "N/A"
A2l-o) Principal Investigator. Leave the "Attached; Go to…" choice selected. The PI of your site will need to provide (1) a signed and dated copy of his/her CV, (2) proof of completion of Research HIPAA training, and (3) proof of completion of the Human Protection training. The Research HIPAA training and the Human Protection training courses are online courses. Please see questions 17 and 18 for details on how to complete training.
A2a-h) Clinical Research Coordinator. Type in the name of the person who will help with the paperwork and day-to-day operation of the study. In most cases, this is the same person as the principal investigator. If this is the case at you site please type in "N/A".
F) Principal Investigator Signature. Type in the name of the person who will serve as the site's principal investigator (PI). Have the site PI sign and date the document.
G) Department Chair/Administrator. Enter "N/A" for Research Pharmacist. Type in the names and titles of individuals that most closely match each item. If your site does not have a person to match the item, type "N/A." Have the above mentioned individuals sign and date the document.
Once the document is complete please return it to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.
11. How do I complete the "Form 2B" document?
To complete the document you will need to follow the directions below:
Indicate the total number of subinvestigators participating in the Research Protocol. Type in the number of subinvestigators participating in the JOINTS study. A subinvestigator at your site is a person who the Project Team and the IRB can turn to when the PI is not available or is no longer be with the project. Think of a subinvestigator as a back-up to the local site PI. This person can be the lead PT, OT, RN, or MD. Most sites will only have one subinvestigator.
1a-e) Subinvestigator. Type in the name of the person(s) who will serve as the site's subinvestigator. Type in additional information requested.
1f-i) Subinvestigator. Leave the "Attached; Go to…" choice selected. The subinvestigator of your site will need to (1) provide a copy of his/her CV that is signed and dated, (2) proof of completion of Research HIPAA training, and (3) proof of completion of the Human Protection training. The Research HIPAA training and the Human Protection training courses are online courses. Please see questions 17 and 18 for details on how to complete training.
Add subinvestigator name(s) to the bottom of the document and have subinvestigator(s) sign the document.
Once the document is complete please return it to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.
12. How do I complete the "Form 8A" document?
To complete the document you will to need to follow the directions below:
A2) Principal Investigator. Type in the name of the person who will serve as the site's PI. This must be a person who is on site at the facility and is overseeing the study.
A2a) Contact number. Type in the phone number of the PI for your site.
A2b)E-mail address. Type in the email address of the PI for your site.
A3) Clinic Coordinator. Type in the name of the person who will help with the paperwork and day-to-day operation of the study. In most cases, this is the same person as the principal investigator. If this is the case at you site please type in "N/A".
D) Investigator Signature. Type in the name of the person who will serve as the site's principal investigator. Have the PI sign and date the document.
Once the document is complete please return to Matt Elrod at 102 Irving St NW, Washington DC 20010.
13. How do I complete the "Investigator Statement of Compliance for the Conduct of Clinical Research" document?
To complete the document you will need to follow the directions below:
Date. Type in the date that you are completing the document.
Signature. Have the principal investigator sign and date the document.
Once the document is complete please return it to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.
14. How do I complete the "JOINTS HIPAA Authorization" document?
To complete the document you will need to follow the directions below:
Page 2. Site PI Name. Type in the name of the person who will serve as the site's PI. This must be a person who is on site at your facility and is overseeing the study.
Page 2 Your Facility. Type in the name of your facility.
Page 3. Site PI Name. Type in the name of the person who will serve as the site's PI. This must be a person who is on site at the facility and is overseeing the study.
Page 2 PI's address. Type in the address of your site PI.
Once the document is complete please return to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.
15. How do I complete the "FDA 3455" document?
This document must be competed by the principal investigator at your site and the subinvestigator(s) at your site. To complete the document you will need to follow the directions below:
" Name of clinical investigator. Type in the name of the person who will sign the document.
Check any boxes that apply. None of the boxes should apply to you.
Name. Type in the name of the person who will sign the document.
Title. Type in the title name of the person who will sign the document.
Firm/Organization. Type in the name of the facility with which the individual who will sign the document is associated.
Date. Type in the date that you are completing the document.
" Have the investigator sign and date the document.
Once the document is complete please return it to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.
17. Who has to provide proof of completion of Research HIPAA training?
The site principal investigator and all site subinvestigators must complete the Research HIPAA training. Please see below for directions.
Make sure that you are using Microsoft Internet Explorer as your web browser.
Review the Research HIPAA Training Material http://mri.medstar.net/departments/ora/HIPAA/documents/hipaahandbook.pdf.
Register, take, click submit, and print a copy of the Research HIPAA Exam. http://mri.medstar.net/departments/ora/HIPAA/hipaatest.htm.
Please send copy of the test to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.
18. Who has to provide proof of completion of Human Protection Course?
The site principal investigator and all site subinvestigators must complete the Human Protection Course. Please see below for directions.
Make sure that you are using Microsoft Internet Explorer as your web browser.
Complete the online Human Protection course by clicking through the web-based study guidehttp://mri.medstar.net/departments/ora/cbt/intro/cbt01.htm).
Complete the course evaluation on-line. (This is how you register.)
Submit the evaluation.
Print the confirmation of your successful completion of the CBT course.
Please send a copy of the confirmation to Matt Elrod at NRH, 102 Irving St NW, Washington DC 20010.