Submission Kit Contents
Consent Forms:
page
Step-by-Step Instructions...................................................................................... 2 Blood and Buccal Swab Collection and Shipping Procedures .............................. 3 English – Adult Patient .................................................................................... 5 English – Pediatric Patient .............................................................................. 8 French – Adult Patient................................................................................... 12 French – Pediatric Patient ............................................................................. 16 German – Adult Patient ................................................................................. 21 German – Pediatric Patient ........................................................................... 25 Italian – Adult Patient .................................................................................... 30 Italian – Pediatric Patient............................................................................... 33 Spanish – Adult Patient ................................................................................. 37 Spanish – Pediatric Patient ........................................................................... 41 Registry Submission Form .................................................................................. 46
If you have questions or need assistance with the process, please contact us at 1-888-826-3847.
Step-by-Step Instructions for Submission
1. Register or sign-in as a physician. 2. Submit case information and create a Participant Number. 3. Complete appropriate consent form. Write Participant Number on the consent form and present it to the patient. 4. Obtain or witness signed informed consent. 5. Collect the buccal swab and blood samples. (See Collection and Shipping of Blood & Buccal Swap samples for instructions). 6. Complete the Registration Submission form. 7. Prepare your submission package. All items should be labeled with the unique Participant Number that was assigned when you registered and created a case. Package should include: Completed Registration Submission Form Original signed Consent Form Buccal swab and blood samples 12 lead ECG (hard copy and electronic format on disk if possible). Please include ECG on drug and ECG of suspect drug if possible. Rhythm strips for arrhythmia documentation if available 8. Ship to: Drug-Induced Arrhythmia Registry Attn: Tina Pearson University of Arizona Health Sciences Center 1501 N Campbell Ave, Rm 2222 PO Box 245018 Tucson, Arizona 85724-5018
If you have questions or need assistance with this process, please contact us at 1-888-826-3847.
Blood and Buccal Swab Collection and Shipping Procedures
Tina Pearson, BSN, MPH, Research Coordinator Last revised: January 23, 2002 Prior to sample collection, please obtain signed informed consent. Call 1-888-826-3847 to determine eligibility to obtain consent. The Human Subjects Committee of the University of Arizona, Tucson, requires that all who obtain consent have documentation of completion of Human Subjects Protection training. Blood Sample Collection: Collect about 10cc of blood in K+-EDTA tubes, and send it overnight to us at the address below. 1. Obtain signed informed consent. 2. Blood should be drawn on Monday-Thursday, except holidays (so that it can be received on a working day). The sample should be shipped by Federal Express on the same day it is drawn. 3. Try to fill the tubes completely - aim to collect at least 10 mL of blood from adults and 5 mL from children. 4. Please label the blood tubes with the patient's identification number and the date and time of the blood draw. 5. Place the blood tube inside a plastic ziplock bag and then inside a properly padded packer or box. Seal the container and place in a second ziplock bag prior to placing in a padded envelope for mailing. 6. Email us at ArizonaCERT@ahsc.arizona.edu to inform that you are sending a sample. Samples must be sent immediately, to minimize breakdown of DNA in the blood. Buccal Swab Sample Collection: 1. Use sterile (individually packaged) cotton swabs that can be placed dry into a clean/sterile container (sleeve, tube, jar, or ziplock bag). 2. If possible, have patient swish water gently around their mouth, for a few seconds only, and spit it out (to remove any large food particles). 3. Rub the tip of the swab firmly along the inside of the cheek for 10-15 seconds. Then seal it into its clean/sterile sleeve/tube/jar/bag. 4. To ensure that an adequate amount of DNA is collected, we currently recommend collecting at least three (3) and up to five (5) such swabs, so repeat step #3 two to four times. 5. Label the clean sterile container(s) with the patient's confidential identifying number (See Registration Submission Form). Storage and Shipping:
Blood and Buccal Swab Collection and Shipping Procedures /2
1. It is preferable that swabs/blood samples be shipped immediately. If swabs cannot be shipped immediately they should be stored at -20°C until they are shipped. 2. Samples may be shipped at ambient temperature (no refrigeration or ice necessary). 3. Label outside of shipping box/envelope as follows: "Store at -20°C on receipt". 4. Ship to: Drug-Induced Arrhythmia Registry Attn: Tina Pearson University of Arizona Health Sciences Center 1501 N Campbell Ave, Rm 2222 PO Box 245018 Tucson, Arizona 85724-5018 Telephone: 1-520-626-2978 5. If blood is being shipped, buccal swabs can be sent in the same envelope as blood.
International Registry for Drug-Induced Arrhythmias
SUBMISSION FORM
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For assistance registering online or in completing this form, call 1-888-826-3847.
Physician Information:
Name: _______________________________ Physician ID #: ___________________ Office Phone: ___________________ email: ________________________________ Person completing Form:__________________________________________________
Patient Information:
Confidential Patient Identifier: _____________________ (obtained by registering on www.QTdrugs.org) Date of Birth (mm/dd/yyyy): ____/____/______ Sex: [ ] Male Race: [ ] Caucasian [ ] African American [ ] Female [ ] American Indian
[ ] Hispanic/Latino
[ ] Asian/Pacific Islander
[ ] Other________________________________________________ Height: ________cm, or ______ft______in Alcohol Use: [ ] Current [ ] Recent [ ] Past [ ] Never
Weight: __________kg, or ________lbs Smoking: [ ] Current [ ] Past [ ] Never [ ] No
Pregnant at time of event? [ ] Yes
[ ] Unknown [ ] Not applicable
Adverse Event Information:
Date and time of Event: ____/_____/______ at ____:______ Suspected Drug: __________________________ Dose:____________ Date started:____/____/______ Describe Event or Problem: _____________________________________________________________ ____________________________________________________________________________________ ____________________________________________________________________________________ Did presentation include: [ ] Palpitations [ ] Seizures [ ] Presyncope [ ] Syncope or fainting spells [ ] Unexplained Death
[ ] Sudden Cardiac Arrest
International Registry for Drug-Induced Arrhythmias
SUBMISSION FORM
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Outcomes attributed to adverse event (check all that apply).
Required for submission to the FDA adverse events reporting program-which we will be happy to do for you. [ ] Hospitalization, for _______ days [ ] Permanent Disability:_______________________________________________________ [ ] Required intervention to prevent permanent impairment/injury [ ] Life-threatening [ ] Death, date (mm/dd/yy) & time: ______/____/_____ at ____:____ [ ] Other: ___________________________________________________________________ Measures taken to terminate event and/or prevent recurrence: (e.g., medications stopped or added, electrolytes repleted, pacemaker or ICD implanted). ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________
Relevant Tests/Laboratory Data at time of event:
Potassium: _________meq/l Magnesium: ________meq/l Creatinine: ________mg/dl
Drug plasma concentration at time of the event: Drug Plasma Conc. (units) Date of Test Time, relative to event (eg. X hrs before, during code, x days after, post -mortem)
International Registry for Drug-Induced Arrhythmias
SUBMISSION FORM
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Electrocardiographic Results:
Please send 12-lead ECG (hard copy and electronic format on disk if possible). Please include ECG on and off suspect drug, if possible. Also, if available, please send rhythm strips for arrhythmia documentation. If unable to send ECG’s please complete information in following table: Baseline ECG (drug-free) Date and time of ECG T wave changes Abnormal U waves QRS duration QT interval (uncorrected) QT interval (corrected) RR interval Did patient have Holter Monitor recording(s) [ ] Yes [ ] No Did patient have Event Monitor recording(s) [ ] Yes [ ] No If yes, please supply report and relevant strips, if available. ____/____/____ at ___:___ Yes [ ] Yes [ ] No [ ] No [ ] Event-related ECG ____/____/____ at ___:___ Yes [ ] Yes [ ] No [ ] No [ ]
_______ msec _______ msec _______ msec _______ msec
_______ msec _______ msec _______ msec _______ msec
Additional information:
May we contact the following individuals if we need more information: [ ] This patient? [ ] Family member(s)? Note: we will never provide test results to these individuals. Please send copies or originals of ECG’s and pertinent rhythm strips with patient’s name obscured. Add Patient Identifier Number from web site registration. Send to: Drug-Induced Arrhythmia Registry Attn: Tina Pearson University of Arizona Arizona Health Sciences Center 1501 N Campbell Ave Rm 2222 PO Box 245018 Tucson, Arizona 85724-5018 Phone: 1-520-626-2978
Reporting Information:
Have you submitted this information to any of the following: [ ] Manufacturer [ ] User Facility [ ] Distributor [ ] FDA/Medwatch If not, we will report this information (preserving physician and subject confidentiality) for you. This will be based on the Classification of Cases as described on the web site.
International Registry for Drug-Induced Arrhythmias
SUBMISSION FORM
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For assistance in completing this form, call 1-888-826-3847.
Pages 4 and 5 can be filled out by the patient or patient’s family.
Patient’s Prior Medical History and Family History: Do you have siblings? [ ] Yes [ ] No Do you have children? [ ] Yes [ ] No
Please circle Y (yes), N (no), or U (unknown) Patient * Palpitations Pre-syncope Syncope or Fainting Spells Seizures Sudden Cardiac Arrest Unexplained Death Long QTc (>450 msec) Torsades de Pointes Ventricular Tachycardia Ventricular Fibrillation Other Cardiac Arrhythmia High Blood Pressure Myocardial Infarction (Heart Attack) Coronary Artery Disease Congestive Heart Failure Cardiomyopathy (Enlarged Heart) Valve Disease Diabetes Mellitus Renal (Kidney) Failure Hepatic (Liver) Failure Deafness, Hearing Loss Other Chronic Illness (Please specify) Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Mother Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Father Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Siblings Male Female Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Children Male Female Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U Y N U
*Excluding current event
International Registry for Drug-Induced Arrhythmias
SUBMISSION FORM
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For assistance in completing this form, call 1-888-826-3847.
Medications (current and history):
Drug Name & Manufacturer Labeled Strength Dose & Route Therapy Dates (Start – Stop) ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ Over the counter medicines ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ Herbals, Dietary Supplements, Others ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ ___/___/___ N/A = not applicable Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Indication (Reason for starting this med) Reason for stopping Did arrhythmia stop after stopping med? Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Did arrhythmia recur after restart of med? Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A Yes No N/A
Prescription Drugs
-
Yes No N/A Yes No N/A Yes No N/A Yes No N/A
Yes No N/A Yes No N/A Yes No N/A Yes No N/A