Provider FAQs
1. What is the “process” of a study?
- Patients become familiar about the study by reading the consent form and speaking to one of our research coordinators to answer questions they may have.
- A short screening process will be done to determine if they are meeting minimal criteria for the study they are interested in.
- If patients meet minimal criteria, a longer screening process is done (usually by phone) which takes about 10-15 mins.
- If this extended screening is successful, then patients will be scheduled for their first screening visit.
- If all study related lab work and diagnostic testing are successful, patients will then proceed to being an active study “subject”.
- Patients will be assigned a “screen number” and a randomization number. Only initials, birthdate and assigned numbers are used to identify them on the data we send to the sponsor.
- Patients will be “randomized” in the study, in otherwords, will be assigned to a specific treatment group described in the consent. Randomization is truly just that, people are placed into “arms” or groups of the study based on a “random” selection that is often computer generated.
- Future visits will be scheduled and study materials will be given.
2. What are the eligibility requirements to participate in the study?
Each study’s requirements are different. A research coordinator will review the specific criteria with you during the screening process.
For specific study information see the “more info” tab under each specific study heading and follow links to: http://www.clinicaltrials.gov
3. What kinds of Medical problems would keep patients from partcipating in a study?
Most IDERC studies require a person to be in relatively good health. Problems that may exclude a person from partcipation are:
- Heart Disease/failure/abnormal ECG
- Stroke history
- Renal (kidney) disease/dialysis
- Use of steroid medications
- Pregnancy (or becoming pregnany during the study)
- Liver disease, Hepatitis, Cirrhosis, HIV
- Substance abuse or dependence
- Active or recent cancer
- Severe psychological conditions
- The research coordinators will review your health history with you during the screening process
4. Will patients be able to take usual medications during the study?
Most of the time, this answer is yes. However, certain medications may not be compatible or preferred while in the study. Patients will be made aware of any changes needed and a substitute medication will be suggested. We will work with primary care providers to make necessary changes if needed.
5. Will patients be able to see their own doctor?
By all means! We expect and encourage all partcipants to maintain their relationships with their primary health care providers. IDERC will only manage the aspects of diabetes management that pertains to the study protocol. All other related health concerns will be managed by patient providers usually responsible for these issues. We are happy to inform all PCP of participation and share results of lab work, diagnostic testing, etc. (with patient permission, of course).
6. Glossary of research terms: http://www.clinicaltrials.gov/ct2/info/glossary
7. For more FAQ’s please visit:
http://www.cancer.gov/clinicaltrials/learning/page1
Even though this is a website for cancer studies, the information is excellent for all persons considering being involved in any kind of clinical research