New Patient Packet (English)

All fields must be completed prior to screening visit for study participation.

Patient Information

Phone numbers

Emergency Contacts

Required information

Please answer the following questions to the best of your ability.

Approximate weight in pounds

Personal Health Information

Substance Intake

Woman’s Health History (if applicable)

If no, complete below.
Reason

Contraceptive Information (applicable to all genders)

Please list below

Allergies or Medication Reactions

Please list below

Current Medications (included Vitamins and Herbal Medicines)

Complete below.

Vaccination History

Name of Vaccine

Surgery History

Hospitalization History

Medical History

Please provided your medical history for each of the following listed below:

1. Skin Problems

2. Lung Disease

3. Intestinal Disease

4. Pneumonia

5. Tuberculosis

6. High Blood Pressure

7. Heart Disease

8. Hepatitis

9. Diabetes Type 1

10. Diabetes Type 2

11. Gout

12. Gallstones

13. Polyps

14. Kidney disease

15. Arthritis

16. Syphilis

17. Gonorrhea

18. Thyroid disease

19. Glaucoma

20. Peptic ulcer disease

21. Positive HIV test

Records Release for Use or Disclosure of Health Care Information

Your permission to use and share health data about you will end 50 years from the date you sign this document.

I authorize the use and disclosure of my health information on as described below:

Information Requested:

I understand I have the right to revoke this authorization in writing at any time, except (1) where uses or disclosures have already been made based upon my original permission, or (2) the authorization was obtained as a condition of securing insurance coverage and the insurer by law has the right to contest a claim or the insurance policy. I understand uses and disclosures already made based upon my original permission cannot be taken back. To revoke this authorization, I must do so in writing to Clinical Trials Management Services at 223 E. Thousand Oaks Blvd., Suite 214, Thousand Oaks, CA 91360.

I understand it is possible that information used or disclosed with my permission may be re- disclosed by the recipient and no longer protected by the Federal Privacy Standards.

CLINICAL TRIALS MANAGEMENT SERVICES LLC.
223 E. THOUSAND OAKS BLVD, SUITE 214 | THOUSAND OAKS, CA 91360
PHONE: 805-906-7800
FAX: 818-475-1347
EMAIL: SITESERVICES@CLINICALTRIALSMANAGEMENTSERVICES.COM

Arbitration Agreement

1. AGREEMENT TO ARBITRATE. It is understood that any dispute as to medical malpractice, that is, as to whether any medical services rendered under this contract were unnecessary or unauthorized or were improperly, negligently, or incompetently rendered, will be determined by submission to arbitration as provided by California law, and not by lawsuit or resort to court process except as California law provides for judicial review of arbitration proceedings. Both parties to this contract, by entering into it are giving up their constitutional right to have any such dispute decided in a court of law before a jury, and instead are accepting the use of arbitration.
2. ALL CLAIMS MUST BE ARBITRATED. I understand that all claims for damages arising from medical services rendered by Clinical Trials Management Services, LLC, and/ or associate or substitute physicians, nurses or employees must be arbitrated. This includes any claim of a spouse, heir, child (born or unborn), or other successor in interest to any such claim.
3. ARBITRATION PANEL. Within 30 days of a demand to arbitrate a dispute, which must be made in writing, the parties shall agree on three medical arbitrators: each party shall select an arbitrator (party arbitrator) and then those two-party arbitrators will appoint the third arbitrator. Each party will bear the costs for their own legal counsel, and other expenses incurred for their own benefit, as well as pro rata share of arbitration expenses.
4. APPLICABLE LAW. I agree that the California Code of Civil Procedure relating to arbitration shall apply without any exception.
5. REVOCATION OF THE AGREEMENT. This agreement may be revoked and canceled by written notice delivered to Clinical Trials Management Services, LLC within 30 days of the signing of this agreement. If notice of revocation of this agreement is not received within 30 days of its signing, the right to cancel the agreement is forever waived.
6. GENERAL PROVISIONS. All the claims based on the same incident, transaction or related circumstance shall be arbitrated in one proceeding. A claim shall be waived and forever barred if (1) on the date the notice hereof is received, the claim, if asserted in a civil action, would be barred by the applicable California statute of limitations, or (2) the claimant fails to pursue the arbitration claim in accordance with the procedures prescribed herein with reasonable diligence.
7. If any provision of this arbitration agreement should be held invalid or unenforceable, the remaining provisions shall remain in full force and shall not be affected by the invalidity of any other provision.
8. ACKNOWLEDGEMENT. By signing this agreement, the signing party acknowledges he/ she discussed to his/her satisfaction any questions he/she may have had regarding the arbitration agreement with Clinical Trials Management Services, LLC, an associate physician, physician assistant, nurse practitioner, or authorized legal representative Clinical Trials Management Services, LLC. I understand that I have a right to receive a copy of this arbitration agreement. By my signature below I acknowledge that I have received a signed and fully executed copy.

Notice: By signing this contract, you are agreeing to have any issue of medical malpractice decided by neutral arbitration and you are giving up your right to a jury or court trial. See article 1 of this contract.

Authorization for Use and Disclosure of My Health Information

The Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) protects patients from the unauthorized use or disclosure of medical information about them and changes the sorts of forms that we ask you to sign and the sorts of permissions that we request.

What is the Purpose of this Authorization?
This Authorization Form asks your written permission to allow certain people and/or groups to use and/or disclose your Protected Health Information for the following research study. You will get a copy of this form after you sign it. You should take as much time as you need to decide whether you wish to permit the use and disclosure of your Protected Health Information for the Research Study. Please feel free to ask questions about any aspects of this Authorization that are unclear to you.

What Health Information May Be Disclosed?
The specific health information about you to be used or disclosed in the research includes all personally identifiable health information concerning you collected or generated as a result of this research. The purpose of the use and/or disclosure of Protected Health Information is to be able to use the information collected about you in the results of the research.

Who May Disclose Your Health Information?
The persons and groups that are authorized to use or disclose your Protected Health Information include the research team (investigators, nurses, data managers, etc.)

To Whom May Your Health Information Be Disclosed?
Persons and groups authorized to receive your Protected Health Information include committees and individuals involved in research oversight as applicable, including its Institutional Review Board, the sponsor(s) of this research and any company with which the sponsor has contracted to oversee the research, the U.S. Food and Drug Administration, the U.S. Office of Human Research Protection, other federal agencies involved with research. rev. 06 October 2009

When Does This Authorization Expire?
This Authorization will end 50 years from the date you sign it. However, you have the right to end this Authorization by withdrawing it, in writing, at any time. If you withdraw permission, the researchers will still be able to use the information already collected. If you withdraw this Authorization, you can no longer actively participate in the Research Study. Your withdrawal must be made in writing and addressed to the Principal Investigator.

Is My Permission Voluntary?
You are not required to sign this form, and you may refuse to do so. Health care providers may not refuse to provide you treatment or other health care services if you refuse to sign this form. However, if you refuse to sign this form, you cannot participate in the Research Study, because the researchers will not be able to access the information they need to conduct their research.

Could My Protected Health Information Be Disclosed Outside the Research Study?
The sponsor of this research and other possible recipients of your health information may not be covered by the HIPAA rules, and therefore they may be permitted to share your health information without your permission. Please refer to the Confidentiality Section of your Research Subject and Information Consent Form for additional information regarding confidentiality outside the Research Study.

Will I Be Allowed to Review My Research Records?
During the course of the Research Study, you will not have the right to see or copy your Protected Health Information obtained or created by the researchers for use in the Research Study. When the Research Study has been completed, you will have the right to inspect or copy these records, with certain exceptions provided under applicable law. If, after the completion of the Research Study, you would like to see or copy your records, please contact for further information.

Subject Certification:

I have read this Authorization, which describes how my Protected Health Information will be used and/or disclosed for the Research Study. I have had the opportunity to ask, and I have received answers to, any questions I had regarding the use and disclosure of my Protected Health Information for the Research Study. I hereby authorize and agree to the use and/or disclosure of my Protected Health Information from which I can be identified, as described above, for the Research Study.

A signed copy of this document is to be given to the Patient; the original will be put in Patient’s file.