Download Template - Joint Clinical Trials Office

yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Document related concepts
no text concepts found
Clinical Trials Summary Template
Please complete the following in its entirety for Interventional or Observational studies
PI Full Name:
Include name and credentials e.g. M.D., Ph.D., etc
Study Contact Full Name:
Research nurse or if none available, study coordinator; include credentials e.g. R.N. etc.
Study Contact Email:
Research nurse or study coordinator e-mail
Study Contact Phone:
Research nurse or study coordinator phone
WCMC IRB Protocol Number:
Study Sponsor Name:
Pharma, biotech, device, NIH (or other institutes), foundations, if department/division (Weill Cornell
Medical College)
Sponsor Protocol Number: Identifier Number (if available):
Title (maximum 255 characters with spaces):
Some protocol titles are extremely long or extremely scientific. In those cases, the sponsor often
provides a shorter/patient friendly title for the consent form or EPIC/eIRB include both short and
long title. The shorter or patient friendly title is preferable.
For study phase use numbers e.g.: 1, 2, 3, 4; no roman numerals
Study Summary:
First sentence/paragraph briefly describes the targeted population—“this clinical trial is
for men and women with…” If the trial is open to patients with various types of diseases,
I list them with bullets in the first paragraph for clarity even though they also appear in
key eligibility to make it clearer to patients (and based on calls from patients, not all
people scroll down the page to eligibility).
Brief background/rationale for the study. Examples:
“Currently available treatments are effective in some patients but many
experience side effects. Therefore, there is a need to find more effective
treatments with fewer side effects,”
o “______stimulates the immune system and may stop cancer cells from growing.
_____ blocks enzymes cancer cells need to grow and survive. It is possible that
the combination of _______ and _________ will be more effective than the drugs
used on their own.”
Brief study summary including, if applicable:
o Randomization arms
o Placebo yes or no
o Placebo definition (“a blank pill/tablet/infusion that looks like ____ but contains
no medicine”)
o Length of time on treatment, length of follow-up
o Usually include brief summary of treatment plan (including number of treatment
cycles for cancer trials) unless it is so complicated it can’t be summarized
succinctly. In those cases, I create a short overall description and send to PI for
o Instead of “treatment continues until disease progression,” I say “will continue
on treatment as long as they are responding to therapy and not experiencing
unacceptable side effects.”
o If applicable, “study participants will be compensated for their time”
Key eligibility:
Please do not include the heavily medical/scientific criteria, like lab values, etc, and
focus on the basics of sex, age range, prior treatments/treatment naïve, etc. In certain
cases when prior treatment with a certain medication is excluded or required, include
that information as well. Format:
o Open to men, women or both/Age range. Example: “Men and women age 18 and
o Diagnosis (using patient-friendly language; “kidney transplant” instead of
“renal allograft;” “cancer” instead of “carcinoma,” etc.
o Prior therapy/treatment naïve if applicable (Examples: “Previously treated with
at least 2 systemic therapies for _____,” “No previous treatment for
__________,” “ Relapsed or refractory after receiving XXX drug,” “Have not
received any treatment for _________” When using “relapsed/refractory,”
include simple definitions
o At the end always add: “Detailed eligibility reviewed when you contact the study
team.” This lets the patient know this is not the full criteria.
o Also, there are theories of “implied action,” meaning that if people read “when
you contact the study team” they may be more likely to do so.
Category (Specify disease/disorder being treated):
Choose one specific disease/disorder name e.g. lymphoma OR diffuse large b-cell lymphoma
Study Type (Interventional or Observational):
Drug/Device (Specify either):
Study Phase (Specify 1, 2, 3, 4):
If your study does not have a phase, please write n/a
Adult or Pediatric (Specify either):
Social Media/Online Accounts:
If you have any social media and/or online accounts, please provide links ie:
Follow the Weill Cornell Lymphoma Program Online:
Please complete the information above and submit the form to the IRB for review and approval. Once
approved forward the Word document to Erica Bersin, Manager, Subject Recruitment &
Communications, WCMC/NYP Joint Clinical Trials Office at [email protected] As well,
forwarding any study updates / closures upon receipt.