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NORIG 2BC - Blood Collection for DNABC109 Mar 09 BC - Blood Collection for DNA

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NORIG 2BC - Blood Collection for DNABC109 Mar 09 BC - Blood Collection for DNA Keyed: ( ) NORIG 2BC - Blood Collection for DNABC109 Mar 09 BC - Blood Collection for DNA Purpose: Document the collection of whole blood for shipment to NIDDK Genetics Repository at Rutgers University for DNA extraction and banking. Complete this form only if the patient signed the consent for genetic research. When: Screening visit s1 or s2 and as needed during follow-up due to a low yield (less than 50 μg) of DNA (during follow-up, use the visit code of the follow-up visit that is open). By whom: Clinical Coordinator and laboratory personnel responsible for collection of whole blood. Instructions: (1) Apply MACO labels specific for the patient and visit to the EDTA vacutainer tubes; these labels are generated by the clinical center upon registration (screening labels) or after randomization (follow-up visit labels). Affix duplicate tube label in item 13. (2) Fill two 10 mL EDTA vacutainer tubes with whole blood (see SOP I, section 6.2). (3) Pack the whole blood tubes in the specimen shippers supplied by the NIDDK Genetics Repository and ship to the NIDDK Genetic Repository at Rutgers University on the same day blood is collected. Ship blood at ambient room temperature. Use the preprinted Federal Express shipping label, marked for Priority Overnight Delivery, to ship whole blood to the NIDDK Genetics Repository Monday-Friday. A. Center, patient and visit identification C. Specimen for Genetics Repository 1. Center code: Attach MACO labels to two 10mL EDTA tubes and fill each with whole blood; invert each tube gently 6 times to mix blood with additives; keep tubes at 2. Patient ID: room temperature until the same day shipment to the NIDDK Genetics Repository (see SOP I, sec- 3. Patient code: tion 6.21). 4. Date of visit: 10. Was blood collected for the NIDDK Genetics Repository at this visit: day mon year Yes ( 1) 5. Visit code: 11. No, (specify reason): ( ) 6. Form & revision: b c 1 2 7. Study: NORIG 2 specify B. Check on consent 15. 8. Did the patient consent to blood draw for 11. Date and time of blood draw DNA banking: a. Date: Yes No ( 1) ( * 2) day mon year b. Time: * You cannot proceed until you get consent. : ( 1) ( 2) 9. Did the patient previously provide blood hour minute am pm for DNA banking in the Gastroparesis 12. Number of 10 mL EDTA tubes: Registry: Yes No 13. Form copy of tube labels: ( * 1) ( 2) NORIG Form BC 15. * Do not draw additional blood for DNA banking. Pt: ccc- 9999, xyz Gender Age, yrs.: XX 14. Phlebotomist: print name Form BC NORIG Revision 1 (09 Mar 09) BC - Blood Collection for DNA 1 of 2 Patient ID: D. Administrative information 15. Clinical Coordinator PIN: 16. Clinical Coordinator signature: 17. Date form reviewed: day mon year Form BC NORIG Revision 1 (09 Mar 09) BC - Blood Collection for DNA 2 of 2 Keyed: ( ) NORIG 2BC - Blood Collection for DNABC221 Jul 11 BC - Blood Collection for DNA Purpose: Complete this form for all registered NORIG participants to document the collection of whole blood for DNA extraction and banking at the NIDDK Genetics Repository at Rutgers University. When: Screening visit s1 or s2 and as needed during follow-up due to a low yield (less than 50 μg) of DNA (during follow-up, use the visit code of the follow-up visit that is open). By whom: Clinical Coordinator and laboratory personnel responsible for collection of whole blood. Instructions: (1) Apply MACO labels specific for the patient and visit to the EDTA vacutainer tubes; these labels are generated by the clinical center upon registration (screening labels) or after randomization (follow-up visit labels). Affix duplicate tube label in item 13. (2) Fill two 10 mL EDTA vacutainer tubes with whole blood (see SOP I, section 6.20). (3) Pack the whole blood tubes in the specimen shippers supplied by the NIDDK Genetics Repository and ship to the NIDDK Genetic Repository at Rutgers University on the same day blood is collected. Ship blood at ambient room temperature. Use the preprinted Federal Express shipping label, marked for Priority Overnight Delivery, to ship whole blood to the NIDDK Genetics Repository Monday-Friday. A. Center, patient and visit identification C. Specimen for Genetics Repository 1. Center code: Attach MACO labels to two 10mL EDTA tubes and fill each with whole blood; invert each tube gently 6 times to mix blood with additives; keep tubes at 2. Patient ID: room temperature until the same day shipment to the NIDDK Genetics Repository (see SOP I, sec- 3. Patient code: tion 6.20). 4. Date of visit: 10. Was blood collected for the NIDDK Genetics Repository at this visit: day mon year Yes ( 1) 5. Visit code: 11. No, (specify reason): ( ) 6. Form & revision: b c 2 2 7. Study: NORIG 2 specify B. Check on consent 15. 8. Did the patient previously provide blood 11. Date and time of blood draw for DNA banking in the Gastroparesis a. Date: Registry: Yes No day mon year ( 1) ( 2) b. Time: 15. : ( 1) ( 2) 9. Did the patient consent to blood draw for hour minute am pm DNA banking: 12. Number of 10 mL EDTA tubes: Yes ( 1) 13. Form copy of tube labels: No, patient did not consent to Genetic Research ( ) 2 NORIG Form BC 15. Pt: ccc- 9999, xyz Gender Age, yrs.: XX 14. Phlebotomist: print name Form BC NORIG Revision 2 (21 Jul 11) BC - Blood Collection for DNA 1 of 2 Patient ID: D. Administrative information 15. Clinical Coordinator PIN: 16. Clinical Coordinator signature: 17. Date form reviewed: day mon year Form BC NORIG Revision 2 (21 Jul 11) BC - Blood Collection for DNA 2 of 2 Keyed: ( ) NORIG 8BH - Baseline Medical HistoryBH110 Mar 09 BH - Baseline Medical History Purpose: To collect baseline history information about the patient. When: Screening visit s1. Administered by: Clinical Coordinator, reviewed by Study Physician. Respondent: Patient. Instructions: The Clinical Coordinator should collect the information by either interview or chart review necessary to complete sections A-E. Attach a MACO label to page 7, Gastroparesis Symptoms Inventory, before separating and giving the questionnaire to the patient for self-administration. The Clinical Coordinator should review the completed questionnaire for missing items or other problems for resolution before the patient leaves the clinical center. Page 7 should be re-attached to the BH form. If a is checked for any item, further review is necessary by the study physician who will determine whether the diagnosis or condition in the Caution item renders the pa- tient ineligible for or unlikely to comply with the requirements of the NORIG trial. If a or is checked for any item, the patient is ineligible for the NORIG trial unless the item can be resolved within the 112 day screen- ing window. The BH form can not be keyed to the data system if there are any Stop or Ineligible items present. The form should be retained in a study file for further evaluation as appropriate. A. Center, visit, and patient identification d. Other (specify): ( 1) 1. Center ID: 2. Patient ID: specify 9. Does the patient report symptoms of 3. Patient code: gastroparesis of at least 6 months duration (do not have to be contiguous) 4. Visit date (date this form is initiated): with varying degrees of nausea, vomiting, abdominal pain, early satiety, or post-prandial fullness: day mon year Yes No ( 1) ( 2) 5. Visit code: s 1 6. Form & revision: b h 1 C. Medical history ( means Caution; condition is exclusionary if 7. Study: NORIG 2 study physician agrees with diagnosis) 10. Has the patient ever been diagnosed with B. Gastroparesis history diabetes Type 1 or 2: Yes No 8. What is the present understanding of the ( 1) ( 2) reason for patient’s gastroparesis (check all that apply) a. Idiopathic: ( 1) 11. Does the patient have a G tube, J tube, central catheter or gastric electrical b. Diabetes: ( ) 1 stimulator: Yes No ( ) ( ) c. Post-surgical (includes gastric surgeries such as 1 2 fundoplication, that may disturb the anatomical physiology of gastric emptying, but excludes other organ surgeries that may result with simi- lar gastroparetic symptoms such as appendec- 12. Does the patient have a hypersensitivity or allergy to any tricyclic antidepressant tomy, cholecystectomy, etc): ( 1) drug: Yes No ( 1) ( 2) Form BH NORIG Revision 1 (10 Mar 09) BH - Baseline Medical History 1 of 8 Patient ID: 13. Has the patient ever been diagnosed with v. Scleroderma: ( 1) or treated for any of the following (check all that w. Malignancy (cancer): ( ) apply; source of information can be interview or 1 chart review) x. Migraine headaches: ( 1) a. Glaucoma: ( 1) y. Hypertension: ( 1) z. Coronary artery disease: ( 1) b. History of seizures: ( 1) aa. Cerebrovascular disease: ( 1) ab. Hyperlipidemia (high cholesterol, high triglycerides): ( ) c. Cardiac arrhythmias: ( 1) 1 ac. Pancreatitis: ( 1) ad. Cholelithiasis: ( 1) d. Pyloric obstruction: ( 1) ae. Gall bladder disease including chronic cholecystitis, gall bladder e. Intestinal obstruction: ( 1) dyskinesia: ( 1) af. Polycystic ovary syndrome: ( 1) f. Inflammatory bowel disease: ( 1) ag. Myopathy: ( 1) ah. Multiple sclerosis: ( 1) g. Thyroid disease (hormonal abnormality): ( 1) ai. Eating disorders (anorexia, bulimia): ( 1) aj. Schizophrenia: ( 1) h. Recent myocardial infarction ak. Bipolar disorder: ( 1) (within past year): ( 1) al. Obsessive compulsive disorder: ( 1) am. Severe anxiety or personality i. Major depression: ( 1) disorder: ( 1) an. Dyslexia or learning problems j. Advanced liver disease: ( 1) including ADHD (attention deficit hyperactivity disorder): ( 1) k. Peptic ulcer disease: ( 1) ao. Other diagnosis #1 (specify): ( ) l. GERD: Gastroesophageal reflux 1 disease: ( 1) specify m. Interstitial cystitis: ( 1) ap. Other diagnosis #2 (specify): ( 1) n.
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