ACRIN 6654
ACRIN Study 6654
Pulmonary Function Test
Institution No.
Participant Initials
Instructions: This form documents the spirometry performed at the enrollment visit. Responses to Parts A and B will be retained at the
site. The RA is to submit only part C of this form via the ACRIN website. Submit part C via paper only in the event of a revised or
corrected form via fax to ACRIN Data Management.
A. Preliminary Questions to Ask Participant Prior to Testing. A “yes” answer will require that spirometry
be postponed. Note: Postpone spirometry for the time(s) indicated.
Have you had a respiratory infection in the past 3 weeks (including today)?
If yes, reschedule tests for 3 weeks from time of resolution of symptoms.
In the past 6 hours, have you used a short-acting inhaled bronchodilator, such as Albuterol®
(brand names Proventil® or Ventolin®) or Ipratropium (brand name Atrovent®)?
If yes, postpone tests for 6 hours or more from the last time of inhalant usage.
In the past 24 hours, have you used a long-acting inhaled bronchodilator, such as Salmeterol
(brand name Serevent®), or a long-acting oral bronchodilator, such as Proventil Repetabs® or
a twice-daily Theophylline (brand name Theodur® or Theobid®).
If yes, postpone test 24 hours or more.
In the past 6 hours, have you used a short-acting oral bronchodilator (such as Proventil® 2 mg
or 4 mg) or an over-the-counter preparation for chest congestion, wheezing or asthma?
1 No
2 Yes*
If yes, postpone test for 6 hours or more from the time the medication was taken.
B. Participant data
Age of participant
Gender (sex) of participant
cm Height of participant (with shoes removed)
6654 PA 3-07-03 1 of 2
If this is a revised or correctedform, please check box and fax ACRIN Study 6654
Institution No.
Participant Initials
C. Spirometry: Perform the spirometry per the recommendations of the American Thoracic Society (ATS)
utilizing the SpiroPro device provided to each study site.
8a. Date of spirometry
Date reflects postponed spirometry date:
1 No
Verify that flow-volume measurements were performed as per ATS criteria:
1 No
From the best trial
FVC% predicted
FEV % predicted
FEV % predicted = 100 x (observed FEV /predicted FEV ) Calculated using the best FEV and best FVC Comments (may include comments on effort, etc.):_________________________________________________________
_________________________________________________________________________________________________________ _________________________________________________________________________________________________________ ___________________________________________________ Signature of person responsible for data
Date form completed (mm-dd-yyyy)
Signature of person entering data onto web

6654 PA 3-07-03 2 of 2

Source: http://www.acrin.org/Portals/0/Protocols/6654/forms/6654pa.pdf


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Novartis Pharmaceuticals Corporation - Currently Marketed Trade Products CR REPORT FINISHED PACK NDC NUMBER MATERIAL MATERIAL DESCRIPTION RESISTANT * EXEMPTION PACKAGING SITE BOTTLE SIZE 0078-0127-05 180-10-40-0CLOZARIL TAB 100MG 1000078-0126-05 180-10-20-0CLOZARIL TAB 25MG 1000078-0126-06 180-10-21-0CLOZARIL UD TAB 25MG 1000078-0127-06 180-10-41-0CLOZARIL UD TAB 1

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