Research
Clinical Trials
There are many ways to gain knowledge regarding who is conducting either a pharmaceutical or device trial that you may wish to become a part of. You can go onto www.clinicaltrials.gov and learn who has what going on. Type in Orthopaedics and you will be amazed at what is going on.
If you are new to clinical research or just want to keep current, please visit : http://www.research.temple.edu/oct/oct_manual.html to get familiar with the guidelines.
Temple has an office of clinical trials located across the street in the Student Faculty Center. Craig Pfizer is the liaison between the pharmaceutical sponsors and for some of the device trials that are conducted at Temple. Arleen Wallen handles the Confidentiality Agreement and Budget for all clinical trials. http://www.research.temple.edu/octl
This is the standard way the documents flow:
| Feasibility Questionnaire |
You may fill this out and email or fax back |
Confidentiality Agreement (CDA) |
Only the University signs off on this. Your signature is not valid on this legal document. It must be forwarded to:
Arleen@temple.edu . She gets it signed by the appropriate people in our legal department and returns it to the sponsor. |
| Study Budget |
Arleen also negotiates the budget along with the contract. |
| Brief Study Synopsis |
This comes after the CDA is signed |
Contact Information Sheet |
Your phone,email, fax, location address where study will be conducted, research coordinator phone, email fax. |
| Setting up the Pre-site visit |
During this visit, a sponsor representative will meet with you and collect your CV and current medical license. They will also meet with your research coordinator and take a tour of the department, out-patient pharmacy if necessary. They will go over the feasibility questionnaire with you and the coordinator. You will then receive a letter stating if you have been accepted to participate in the research study. |
Preparing your regulatory packet for IRB Submission |
If the study is a Phase II, IIa, IIb - IRB is Temple IRB to use
http://www.research.temple.edu/irb
If the study is a Phase III, or IV - WIRB is the IRB to use
(Western institutional review board) http://www.wirb.com/content/quick_download_forms.aspx |
| Investigator Meeting (IM) |
Principal Investigator and Research Coordinator must attend the IM. If the principal investigator cannot attend, a sub-investigator must go. |
IRB Approval |
After your site gets the IRB approval letter, you will then be contacted by the sponsor monitor who will conduct the |
| Site Initiation Visit (SIV) |
After the SIV, that will trigger shipment of source documents, regulatory binder and study drug. Once these items have arrived, you can begin enrollment can begin. |
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