What if I didn’t receive my Informational Packet in the mail or via email?
Informational packets normally contain your Study Summary or Informed Consent Form (ICF), directions to our office where you have your appointment. Most importantly, it contains the Registration Forms necessary to conduct your screening visit. You can receive this information from us by mail, by email, by clicking the Registration Form button here. It will take you to our online fillable form. It is about 7 pages long and most patients have it completed in 15 minutes. Once completed the form is automatically transmitted back to us for your appointment. You should also receive a copy in your inbox. Since every study will require a whole new form, we recommend you keep one online for fast and easy access in the future.
What is a clinical trial?
A clinical trial is a research study designed to answer specific questions about investigational drugs. Tests are conducted according to strict rules set by the Food and Drug Administration (FDA).
Who can participate in a clinical trial?
Each clinical trial has its own particular requirements as well as its own exclusion criteria. In general, if you are 18 years of age or older, can read and understand the clinical trial study consent form and can are able to travel to our offices for the clinical trial study visits, you may be eligible to participate. Please contact Northern California Research for clinical trial study information and your qualifications for specific studies of interest to you.
What are the benefits to me of participating in a clinical trial?
There are a wide variety of benefits to participating in a clinical trial. It really depends on one’s own perspective. We like to say one of the benefits is discovering what we call “one of the best kept health care secrets in the world”. Others might say it is the generous payment (stipend) received for participation. The fact there is never any cost to participate and no obligation to stay in the study is always a benefit.
If I agree to participate in a clinical trial, what are my obligations?
As a volunteer for a clinical trial, you are agreeing to participate in the study and follow the instructions and requests as necessary to be compliant.
If you determine that you do not have the time to participate in a clinical trial, you may leave the study at any time for any reason. As a condition of your departure from a clinical trial, we ask that you contact the study coordinator at Northern California Research, return any unused medication and allow time for an exit physical exam/procedure.
Why should I participate in a clinical trial?
You are taking part in medical science history! You have the opportunity to participate in treatment before it becomes widely available. By playing a more active role in your own healthcare, you may benefit from an alternative course of treatment that you or your physician might not otherwise have known about. You will receive expert medical care during the clinical trial. And many of our studies are investigational use of an already approved drug, treatment or device.
Are there any risks to participation in a clinical trial?
Many clinical trial studies require the use of a placebo (an inactive substance that has no therapeutic value). You may receive a placebo in a clinical trial, which means you will not be receiving therapeutic effects. You may have a reaction to a medication used in a study or experience some sort of unpleasant side effect. These types of risks will be known to you when you before the study thru the Informed Consent Process.
What if I experience a new medical problem outside of the scope of the clinical trial?
There may be instances during the study when unrelated medical issues are uncovered. The level of severity with this issue will greatly determine how we move forward; as well as, what we can or can not do to help you resolve these issues. We will not take the place of your physician. With your permission, we can explain to him/her our findings and provide them with all of your study related care.
What happens after a trial?
After a study phase is complete, the data is collected. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Typically it is then submitted to the Food and Drug Administration (FDA) for approval.
If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug-in terms of its safety, effectiveness, and cost-to other drugs already on the market or assess a drug’s long term impact on the quality of a person’s life.
What should I tell my doctors?
Please discuss any research study with your doctor.
We work in conjunction with your doctor or primary care provider. Your participation in a research study at Northern California Research is in addition to the care of your doctor. Only with your prior authorization, will we share with your doctor information or results about you and your participation.
Will the drug be available after the study has ended?
FDA approval of a drug is often a long process, but if the results of a study show the drug to be effective, a study drug may become available, or FDA-approved soon after a study has ended. Sometimes, open-label (everyone in the study is on the study drug) extensions follow a research study.
What is a visit like at Northern California Research?
We try to make each visit a comfortable and enjoyable one. We understand the medical condition you have, and our doctors and staff work with patients like you every day. Our staff is well trained and they are experts at what they do. We are not in a hurry and have the time to listen to your concerns and needs. We invite questions and enjoy helping you understand your condition and our clinical studies.
Who are the doctors at Northern California Research?
What are the typical services provided by Northern California Research at no charge?
Qualified study participants may receive:
- Physical examinations
- Laboratory tests
- Nutritional counseling (varies per study)
- Specialized tests (e.g. bone density, mammograms, x-rays)
- Electrocardiograms (ECG)
- Vital signs: Blood pressure, Pulse, Weight, Height
- Physician evaluation
- Study medication
- Compensation or stipend, once enrolled into study
Your information privacy:
Medical patients and clinical trial participants need to trust that the healthcare system will keep their personal health information private. The policies and procedures implemented at Northern California Research fully comply with those of the Health Insurance Portability and Accountability Act (HIPAA) that was passed in August 1996 and became effective in April 2003.