Consequence of inspiration of tiotropium one time daily18 microgram versus salmeterol twice daily 50 microgram on clip to first aggravation in COPD patients ( a randomized, double-blind, double-dummy, parallel group, annual survey ) .
Title of test: Consequence of inspiration of tiotropium one time daily18 microgram versus salmeterol twice daily 50 microgram on clip to first aggravation in COPD patients ( a randomized, double-blind, double-dummy, parallel group, annual survey ) .
Aims: The primary aim of this survey is to compare the consequence of tiotropium ( 18 Aµg ) inspiration capsule via HandiHalerA® and salmeterol ( 50 Aµg [ 2 propulsions of 25 Aµg ] ) via MDI on COPD aggravation.
Methodology: Randomised, double-blind, double-dummy, parallel group design
No. of patients:
entire: 6,800 # randomised
each intervention: 3,400 # randomised
evaluable [ that was given in the templet. I have no thought what to make with it i?? ]
Diagnosis and chief
standards for inclusion:
Outpatients of either sex, aged a‰? 40 old ages with a diagnosing of COPD ; post-bronchodilator FEVA1 a‰¤ 70 % predicted ; FEVA1 a‰¤ 70 % of FVC post- bronchodilator ; at least one aggravation within the past twelvemonth necessitating intervention with antibiotics and/or steroids and/or hospitalization ; smoking history a‰? 10 pack-years. Complete inclusion/exclusion standards can be found in Section 3.3.
Test merchandise ( s ) : Tiotropium, BA 679 BR – SpirivaA®
dosage: 18 Aµg day-to-day ( in the forenoon )
manner of admin. : Oral inspiration via HandiHalerA®
Mention therapy: Salmeterol – SeverentA®
dosage: 25 Aµg twice daily ( in the forenoon and in the eventide )
manner of admin. : Oral inspiration via MDI
Duration of intervention: 52 hebdomads
Name of company:
Boehringer Ingelheim
Tabulated Trial Protocol
Name of finished merchandise:
SpirivaA®
Name of active ingredient:
Tiotropium, BA 679 BR
Protocol day of the month
21 May 2007
Trial figure
205.389
Planned test period
Dec 2007 to Dec 2009
Standards for efficaciousness:
Primary End point: The primary end point is clip to first COPD aggravation during the 52 hebdomad randomised intervention period. A COPD aggravation will be defined as a composite of respiratory events/symptoms ( increase or new oncoming ) of more than one of the followers: cough, phlegm, wheezing, dyspnea, or chest stringency with a continuance of at least three yearss necessitating intervention with antibiotics and/or systemic steroids and/or hospitalization.
The oncoming of an aggravation is defined as the oncoming of the first new or increased reported symptom. The terminal of the aggravation should be recorded as defined by the research worker.
Merely COPD aggravations with oncoming during randomised intervention will be included in the analysis.
Secondary End points: 1. Happening of at least one aggravation
2. Number of COPD aggravations
3. Time to first hospitalization due to COPD aggravation
4. Happening of at least one hospitalization due to COPD aggravation
5. Number of hospitalization due to COPD aggravation
6. Time to premature discontinuance of test medicine
7. Happening of premature discontinuance of test medicine
8. Pre-dose forenoon PEFR measured by patients at place during the first
four months of randomized intervention ( hebdomadal agencies will be calculated )
9. Time to first COPD aggravation or clip to discontinuance of survey
medicine because of deterioration of implicit in disease, whichever comes
foremost
Merely COPD aggravations with oncoming during randomised intervention will be included in the analysis.
Standards for safety: Serious inauspicious events, inauspicious events taking to intervention discontinuance, all-cause mortality during intervention with survey medicine, all-cause mortality including followup of critical position frompatient who prematurely discontinue intervention, physical scrutiny
Statistical methods: Cox relative jeopardies theoretical account, ANCOVA, Cochran-Mantel-Haenszel-test, Poisson arrested development
Inclusion Standards:
All patients must hold a diagnosing of chronic clogging pneumonic disease ( COPD ) and must run into the undermentioned standards at Visit 1:
Patients must hold comparatively stable, moderate to really terrible air passage obstructor with a post-bronchodilator FEV1 a‰¤ 70 % of predicted normal and FEV1 a‰¤ 70 % of FVC post-bronchodilator ( i.e. 30 proceedingss after inspiration of 4 whiffs of 100Aµpg salbutamol or tantamount SABA ) .Predicted normal values will be calculated harmonizing to ECSC [ R94-1408 ] .
For Height measured in inches
Males:
FEV1 predicted ( L ) = 4.30 x ( height ( inches ) / 39.37 ) -0.029 ten age ( year ) – 2.49
Females:
FEVl predicted ( L ) = 3.95 x ( height ( inches ) / 39.37 ) -0.025 ten age ( year ) – 2.60
For tallness measured in meters
Males:
FEVl predicted ( L ) = 4.30 x ( height ( meters ) ) – 0.029 ten age ( old ages ) -2.49
Females:
FEV1 predicted ( L ) = 3.95 x ( height ( meters ) ) – 0.025 ten age ( old ages ) – 2.60
All patients must subscribe an informed consent consistent with ICH-GCP guidelines prior to engagement in the test.
Male or female patients 40 old ages of age or older.
Patients with a history of at least one aggravation within the past twelvemonth necessitating intervention with either antibiotics and/or steroids and/or hospitalization.
Patients must be CWTentor ex-smokers with a smoking history of a‰? 10 pack-years.
( Patients who have ne’er smoked coffin nails must be excluded. )
Pack Years = figure of cigarettes/day x old ages of smoke
20
Patients must be able to execute all study-related processs including technically acceptable pneumonic map trials ( PFTs ) .
Patients must be able to inhale medicine in a competent mode from the HandiHalerA® ( Appendix 10.1 ) and a metered dosage inhalator ( MDT ) ( Appendix 10.2 ) .
Patients must be able to keep records ( patient daily diary card ) during the survey period as required in the protocol.
Exclusion Standards:
Significant diseases other than COPD. A important disease is defined as a disease or status which, in the sentiment of the research worker, may set the patient at hazard because of engagement in the survey or may act upon either the consequences of the survey or the patients ‘ ability to take part in the survey.
Patients with a diagnosing of asthma.
Patients with a dangerous pneumonic obstructor, or a history of cystic fibrosis.
Patients with known active TB.
Patients with a known diagnostic prostate hyperplasia or vesica neck obstructor. Patients with symptomatically-controlled prostate hyperplasia on medicine may be included and should go on their medicine.
Patients with known narrow-angle glaucoma.
Patients with a history of myocardial infarction within the twelvemonth prior to Visit 1.
Patients with a history of hospital admittance for bosom failure within the twelvemonth prior to Visit 1.
Patients with cardiac arrhythmia necessitating medical or surgical intervention.
Patients with terrible cardiovascular upsets.
Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other constituent of the medicine bringing system.
Patients with known moderate or terrible nephritic inadequacy ( known creatinine clearance of a‰¤A 50 mL/min ) .
Patients with untreated known hypokalaemia.
Patients with untreated known hyperthyroidism.
Patients with brittle/unstable diabetes mellitus.
Patients with a history of and/or active important intoxicant or drug maltreatment. See exclusion standard 1.
Patients who have taken an investigational drug within 30 yearss or six half-lives ( whichever is greater ) prior to Screening Visit ( Visit 1 ) .
Use of systemic corticosteroid medicine at unstable doses ( i.e. less than six hebdomads on stable dosage ) or at stopping points in surplus of the equivalent of 10 milligrams prednisolone per twenty-four hours or 20 milligram every other twenty-four hours.
Pregnant or nursing adult females or adult females of childbearing possible non utilizing a medically approved agencies of contraceptive method ( i.e. unwritten preventives, intrauterine devices, stop or subdermal implants e.g. NorplantA® ) for at least three months prior to, and for the continuance of the test.
Previous engagement ( reception of randomized intervention ) in this survey.
Patients who are presently take parting in another survey.
Patients with any respiratory infection or COPD aggravation in the four hebdomads prior to the Screening Visit ( Visit 1 ) or during the run-in period should be postponed. In the instance of a respiratory infection or COPD aggravation during the run-in period, the latter may be extended up to four hebdomads.
FLOW CHART
Trial Time period
Screening/
runAA-in period
Treatment period
Follow-up
Visit
1
2
3
4
5
6
Calendar month
-0.5
0
2
4
8
12
Day
-14A±3
1
60A±7
120A±7
240A±7
360A±7
Informed consent
X1
Demographics
Ten
Medical history
Ten
Inclusion / exclusion standards
Ten
Ten
Physical scrutiny
Ten
Ten
Critical marks ( seated )
Ten
Ten
Document old medicine
Ten
Urine gestation trial
X2
Laboratory trial for genotyping
Ten
Training in extremum flow measurings
Ten
Training in usage of MDI and HandiHalerA®
Ten
Issue Ipratropium MDI 20 Aµg
X3
Issue deliverance medicine
Ten
Ten
Ten
Ten
Ten
Direction on finishing diary card
Ten
Issue Peak Flow Meter/Diary
Ten
Review of patient journals
Ten
Ten
Ten
Ten
Dispense test medicine
Ten
Ten
Ten
Ten
Ten
Attendant medicine
Ten
Ten
Ten
Ten
Ten
Ten
PFTs ( FEV1 and FVC )
Ten
Review of medicines and medicine limitation processs
Ten
Ten
Ten
Ten
Ten
Serious inauspicious events
Ten
Ten
Ten
Ten
Ten
Ten
Non-serious inauspicious events taking to discontinuance
Ten
Ten
Ten
Ten
Ten
Review of COPD aggravation
Ten
Ten
Ten
Ten
Ten
Trial Time period
Screening/
runAA-in period
Treatment period
Follow-up
Aggravation questionnaire
Ten
Randomization
Ten
Collection of all test medicine
Ten
Ten
Ten
Ten
Ten
Roll uping information sing aggravation and HCRU
Ten
Ten
Ten
Ten
Issue new “ intervention battalion ”
Ten
Ten
Ten
Administration of blinded survey medicine on survey site
Ten
Ten
Ten
Ten
PEFR performed by patient ( one time daily )
Ten
Ten
Ten
Ten
( Ten )
Termination of test medicine
Ten
Review of smoke position
Ten
Ten
Ten
Ten
Site survey staff to phone topic
Phone contact will be performed on yearss -14A±3, 1, 30A±7, 60A±7, 90A±7, 120A±7, 150A±7, 180A±7, 210A±7, 240A±7, 270A±7, 300A±7, 330A±7 and 360A±7.4
1 Patients must subscribe informed consent consistent with ICH-GCP guidelines prior to take parting in any survey related processs.
2 Urine gestation trials will be performed on adult females of childbearing possible.
3 Ipatropium MDI 20Aµg ( two whiffs four times daily ) will be issued to patients who were treated with tiotropium before the survey for the following 14 yearss.
4 Patients who withdraw prematurely from the survey will be followed for critical position via phone calls until their predicted normal issue day of the month from the test and will be performed on the originally scheduled visits 4, 5 and 6 )
PAREXEL- Akademie
PAREXEL International GmbH
Klinikum Westend, Haus 18
Spandauer Damm 130
14050 Berlin
University of Wales
University Registry
King Edward VII Ave
Cardiff CF 10 3NS
United Kingdom
BSc ( Hons ) in Clinical Research
Year THREE
SEMESTER SIX
Faculty
Conducting clinical tests /
Monitoring II
Coursework
Adapt the provided informed consent templet to run into the demands.
United states navy: 01711866833713
words:
Coach:
27 October 2010
Patient Trial Ident. No. : the research worker enters the patient test designation No. here
Centre No. : the research worker enters the Centre No. here
Study Number: 205.389
Patron: Boehringer Ingelheim Pharma GmbH & A ; Ko.KG
Binger Str.173
55216 Ingelheim
Germany
Information for Patients
dated
3 May 2007
Dear patient,
Your medical history shows that you are suited to take portion in a clinical test. This research survey of an investigational medicine is conducted to handle Chronic Obstructive Pulmonary Disease ( COPD ) and is sponsored by Boehringer Ingelheim Pharma GmbH & A ; Co. KG. The name of the survey medicine is tiotropium and will be compared to salmeterol.
Clinical tests are necessary to obtain or supplement the findings on the efficaciousness and tolerability of medicative merchandises. The Medicines Act hence stipulates that new drugs have to be investigated under clinical conditions. This test and Informed Consent Form has been assessed positively by the competent Ethics Committee and approved by the competent authorization ( organic structures to protect the patients ‘ rights ) .
In the following the purpose of the research survey, processs, hazards, benefits uncomfortablenesss, insurance and safeguards which may ensue for you by take parting in the survey are described. This Informed Consent Form besides states your right to retreat from the clinical survey or decline engagement at any clip, without giving a ground.
Engagement in a clinical test is ever voluntary and will hold no impact on the quality of your intervention. As a patient you must first give your written consent to take part in a clinical test. Please read the text below carefully and make non waver to inquire inquiries.
Merely sign the Declaration of Informed Consent one time you have read the Information for Patients and this Declaration of Consent, one time the research worker has answered all of your inquiries to your satisfaction, if you are prepared to take portion and one time you are clear about your rights and duties as a participant in this clinical test.
Title of the clinical test
Consequence of inspiration of tiotropium one time daily18 microgram versus salmeterol twice daily 50A microgram on clip to first aggravation in COPD patients ( a randomized, double-blind, double-dummy, parallel group, annual survey ) .
Why is this test being carried out?
COPD is a lung disease with airflow restriction which makes it difficult to take a breath for affected individuals. There is late no remedy available for COPD. During the disease patterned advance a gradual aggravation is common. A chief medicine category for the intervention of COPD are the alleged bronchodilators which can be divided into beta-agonists and anticholinergics. Both have the consequence to maintain the respiratory system unfastened and decrease secernment in the lung.
In anterior clinical tests tiotropium, belonging to the category of long-acting anticholinergics, showed positive effects compared to placebo and competitory medicines. Most significantly was the decrease of aggravations. In comparing with salmeterol, which is a long-acting beta-agonist, clinical surveies have shown that tiotropium delayed the oncoming of the first aggravation and reduced the figure of hospitalizations.
The purpose of this clinical test with tiotropium and salmeterol is to compare the consequence of tiotropium ( 18 microgram ) inspiration capsule via HandiHalerA® and salmeterol ( 50 microgram ) via MDI on COPD aggravations.
6,800 patients in approximately 900 survey Centres will take part in the survey. To guarantee dependable and indifferent consequences the survey is dual blinded. This means that neither you nor your physician will be cognizant of which of the two medicines you receive. Since salmeterol is given twice daily and tiotropium one time day-to-day and the devices for disposal have different forms, it would be possible that you and your physician find out which medicine you receive. For this ground we besides had to include placebo in the survey. A placebo is a medicine which has no active ingredient and therefore has no active influence on your organic structure. This means you will have either tiotropium one time day-to-day and placebo twice daily or salmeterol one time day-to-day and placebo twice daily. There is no possibility that you merely receive placebo without salmeterol or tiotropium.
Furthermore, the intervention will be allocated indiscriminately to each patient, like throwing a die. The opportunity you will be assigned to either tiotropium one time day-to-day plus placebo or salmeterol twice day-to-day plus placebo is 50 % . However, should it turn out necessary, your research worker can find at any clip which drug you were given.
If you agree to everything stated in this Informed Consent and are willing to take part in the survey you should follow the survey processs and should be present at all survey visits described below. In instance any side effects occur to you the physician should be informed.
Please store the medical specialties that you are given during the test in a safe topographic point to guarantee that they are out of the range of kids or other individuals unable to measure the possible hazards of drugs. You are non permitted to give this medical specialty to other individuals. Please observe the storage instructions on the label.
Fresh medicine and dust of medicine ( inspiration capsules and empty inhalators ) must be returned to the research worker.
What other intervention options are at that place?
The followers options are available for the intervention of your disease:
Inhaled anticholinergics such as ipratropium act as bronchodilator
Short-acting beta-agonists such as salbutamol and long-acting beta-agonists such as formoterol, Elixophyllins are besides bronchodilators with a loosen uping consequence of the lung tubings
corticoids such as beclomethasone and Orasone may diminish redness in the lungs
The above named medicines are approved by different Regulatory Authorities and may hold differing benefits and hazard which may or may non use to you single disease status. They are taken either as tablets or from an inhalator.
Furthermore, other experimental interventions may be available.
During the first run-in period of the survey yearss, your physician will be asked non to order long-acting anticholinergics, short-acting anticholinergics entirely or in combination, antihistamines, antileukine/leukotriene receptor adversaries, cromolyn Na or nedocromil Na. During the intervention period
You do non hold to take part in this survey to have intervention for COPD. Please inquire your physician to discourse intervention options with you.
Who should non take portion in this clinical test?
Pregnant adult females should non take portion in clinical tests.
Should you go or surmise that you have become pregnant during the clinical test, delight inform your research worker instantly.
During your engagement in this clinical test you must utilize dependable prophylactic steps ( e.g. preventive pill ) . Please inquire your research worker if you have any inquiries on this point. This is because no surveies have been conducted to day of the month to look into whether or non tiotropium or salmeterol causes harm to the unborn kid if it is taken during gestation.
Womans who are suckling may non take portion in this clinical test either as tiotropium and salmeterol could go through into the organic structure of the baby with the chest milk and cause harm to the kid.
All adult females must undergo a gestation trial before the start of the clinical test. Exceptions to this are adult females after the climacteric and those who have been surgically sterilized. However, a gestation trial can merely faithfully observe a gestation some yearss after construct.
Furthermore, you are non eligible to take portion in this survey if you:
Suffer from any other disease evaluated as important by your research worker.
Suffer from following medical conditions or diseases:
Asthma.
Dangerous pneumonic obstructor.
Active TB.
Diagnostic prostate hyperplasia or vesica neck obstructor.
Narrow-angle glaucoma.
Myocardial infarction within the twelvemonth prior to Visit 1.
Cardiac arrhythmia necessitating medical or surgical intervention.
Severe cardiovascular upsets.
Hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other constituent of the medicine bringing system.
Moderate or terrible nephritic inadequacy ( known creatinine clearance of a‰¤A 50 mL/min ) .
Untreated known hypokalaemia.
Untreated known hyperthyroidism.
Brittle/unstable diabetes mellitus.
Have a history of:
Cystic fibrosis.
Hospital admittance for bosom failure within the twelvemonth prior to Visit 1.
History of and/or active important intoxicant or drug maltreatment.
Have taken an investigational drug within 30 yearss prior to Screening Visit ( Visit 1 ) .
Used systemic corticosteroid medicine at unstable doses ( i.e. less than six hebdomads on stable dosage ) .
Previously participated ( reception of randomized intervention ) in this survey.
Are presently take parting in another survey.
Have any respiratory infection or COPD aggravation in the four hebdomads prior to the Screening Visit ( Visit 1 ) or during the run-in period
Have ne’er smoked coffin nails
How and where will this clinical test be conducted?
You will come to the infirmary or clinic for a screening visit. 14 yearss subsequently if eligible you will go through intervention period from V2 to V6 over 52 hebdomads. Additionally eight telephone interviews will be performed on yearss 30, 90, 150, 180, 210, 270, 300 and 330 ( +-7 yearss )
The survey intervention continuance will be 52 hebdomads. You will be in the test for a upper limit of 54 hebdomads # . The following survey processs will be performed on the different visits:
Visit 1 ( testing visit )
The first survey visit
Blood sample for familial analysis ( after given informed consent )
PEFR one time daily from V1 to 4
Med his, critical marks, Physical scrutiny on V1 and 6
Evaluation of in-ex on V1 and 2 ( if non run into ex from test )
Previous therapy and current medicine
Trained and supply extremum flow metre
PEFR one time daily ( in the forenoon before taking survey Master of Educations )
Trained on usage of MDI and HandiHalerA®
Rescue medicine
Patient journal ( instructions on finishing )
Doc will look into for current medicine
Explanation of aggravation questionnaire
Visit 2
The randomized interventions should be taken at about the same clip each forenoon between 7:00 and 10:00 ( +- 30 mins ) and the eventide
What must be observed during the clinical test?
As concomitantly taken medicine may hold an influence on the ability to take portion in this survey or may act upon the consequences, you should discourse all concomitantly taken medicine with the research worker.
Furthermore, the medicine taken during the survey may interact with other medicine. Therefore any physician handling you should be informed that you are taking portion in this clinical test, particularly if you have to be treated in an exigency room.
In rare instances the medicine taken during the survey may hold an influence on your ability to drive or utilize machines.
What are the possible hazards involved in this clinical test?
Treatment with the survey drugs can do inauspicious effects or other symptoms. Temporary or lasting side effects can happen with any medicine. The side effects and ailments observed to day of the month include:
Tiotropium:
Adverse consequence
Frequency
Nervous system upsets
Dizziness
Uncommon
Concern
Uncommon
Taste upsets
Uncommon
Eye upsets
Vision blurred
Rare
Intraocular force per unit area increased
Rare
Glaucoma
Not known
Cardiac upsets
Tachycardia
Rare
Palpitations
Rare
Supraventricular tachycardia
Not known
Atrial fibrillation
Not known
Respiratory, thoracic and mediastinal upsets
Bronchospasm
Uncommon
Cough
Uncommon
Sore throat and other application site annoyance
Uncommon
Dysphonia
Uncommon
Nosebleed
Rare
Sinusitis
Not known
Adverse consequence
Frequency
Gastrointestinal Disorders
Dry Mouth and pharynx
Park
Oral moniliasis
Uncommon
Nausea
Uncommon
Gastrooesophageal reflux disease
Rare
Constipation
Rare
Dental cavities
Not known
Dysphagia
Not known
Intestinal obstructor, including ileus paralytic
Not known
Skin and hypodermic tissue upsets, Immune system upsets:
Rash
Rare
Urtications
Rare
Pruritus
Rare
Other Hypersensitivity ( including immediate reactions )
Rare
Angioneurotic hydrops
Not known
Renal and Urinary Disorders
Dysurias
Rare
Urinary keeping
Rare
Urinary piece of land infection
Rare
Salmeterol:
Adverse consequence
Frequency
Immune system upsets
Hypersensivity including:
Exanthem
Uncommon
Oedema
Not known
Angiooedema
Not known
Bronchospasm and anaphylaxia
Not known
Nervous system and sense organe upsets
Tremor
Park
Concern
Park
Sweating, restlessness, gustatory sensation perversion
Uncommon
Metamorphosis and nutritionary upsets
Hyperglycemia
Very rare
Cardiovascular upsets
Palpitations
Park
Tachycardia
Uncommon
Arrhythmia ( incl. atrial fibrillation, supraventricular tachycardia and extrasystoles )
Not known
Increase or lessening of blood force per unit area
Rare
Respiratory, thoracic and mediastinal upsets
Coughing
Uncommon
Application site annoyance
Not known
Bronchospasm
Not known
Adverse consequence
Frequency
Skeletal musculus, hypodermic tissue and bone upsets
Muscle spasms
Park
Arthralgia
Not known
Others
Hypokalemia
Uncommon
Frequency:
really common & gt ; 1/10 ; common & gt ; 1/100, & lt ; 1/10 ; uncommon & gt ; 1/1,000, & lt ; 1/100, rare & gt ; 1/10,000, & lt ; 1/1,000 harmonizing to frequence convention
Higher doses of the merchandise can bring on more frequent and more intensive side effects.
As already mentioned in subdivision 4 that in instance you or your spouse get pregnant, the unborn babe may be at hazard. If you are sexually-active you must utilize any signifier of birth control from visit 1 to see 6.
At the testing visit a blood sample will be taken from you. This intercession may do contusions and uncomfortableness every bit good as giddiness. The sum of blood needed will be about 5A milliliter ( one teaspoon ) . #
Please advise your research worker about all symptoms, side effects, ailments, diseases or hurts happening in the class of the clinical test. If these are terrible, advise your research worker instantly, if necessary by telephone.
How can I profit from take parting in this clinical test?
Use of tiotropium or salmeterol may convey about an betterment in your symptoms. These drugs have been shown to better lung map of patients with COPD. This can take to less dyspnoea and fewer aggravations. However, it is besides possible that you derive no direct benefit to your wellness from take parting in this test. Furthermore, the really thorough medical scrutiny and monitoring during this survey may profit your wellness.
The consequences of this clinical survey are designed to assist enable us to measure intervention options in COPD.
Your research worker will inform your household physician that you are taking portion in this clinical test.
Will I be informed of any new findings refering the trial drug during the test?
The research worker will inform you instantly of any new findings made in connexion with this clinical survey which could be of significance for you. On the footing of such findings, you may wish to reconsider your determination to go on with the clinical test.
Am I insured during the clinical test?
Should utilize of tiotropium or salmeterol or the duplicate placebos or any of the steps taken impacting your organic structure in the class of the clinical test cause harm to your wellness, the insurance conditions provide for insurance screen in conformity with subdivision 40, paragraph ( 3 ) of the Medicines Act. Appropriate insurance has been taken out for you with the
Haftpflichtverband der Deutschen Industrie
Versicherungsverein auf Gegenseitigkeit.
Riethorst 2
30659 Hannover
Tel. No. : 0511 – 645-0
Fax No. : 0511 – 645-4062
Policy no. : 95-000211-03228
The insurance conditions province expressly that harm to wellness will non be covered where this is a consequence of your intentionally disregarding the expressed instructions of those individuals commissioned to transport out this clinical survey.
If, either intentionally or due to gross carelessness, you fail to carry through an duty under the footings of the insurance contract, this can take to the loss of insurance screen.
For the continuance of the clinical test you, as the insured, may undergo other medical intervention merely after audience with the physician transporting out the clinical test. This does non include medical exigencies, and intervention carried out in an exigency will non take to loss of insurance screen.
Any harm to wellness which could be a consequence of the clinical test must be reported to the insurance company instantly.
The research worker will so make up one’s mind if you can go on with the clinical test in position of the other medical intervention planned.
Your research worker has transcripts of the General Insurance Conditions for Clinical Trials with Medicinal Products to which you may mention. You will be given a transcript of the insurance conditions on petition at no charge.
Can I retreat from the clinical test?
As your engagement in this clinical test is voluntary, you may retreat your consent to take portion at any clip, without saying your grounds and without endangering your continued medical intervention.
If you decide to retreat prematurely from the test or if your engagement is terminated prematurely for one of the grounds given below, it is of import for your ain safety that you undergo a concluding check-up scrutiny. This normally involves a physical scrutiny.
Under certain fortunes it is possible that your research worker or the company as patron of this survey will make up one’s mind that you should be withdrawn prematurely from the clinical test without your anterior consent. This may go on for the undermentioned grounds:
You can non or can no longer run into the demands for engagement in the clinical test.
You develop another serious disease.
Your research worker has the feeling that continued engagement in the clinical test is non in your involvements.
The patron has decided to stop or end the clinical survey prematurely. ( eg: if it is no longer acceptable to handle patients with placebo or if new side effects become known that preclude continuance of the clinical test )
Will the informations be treated confidentially?
The undermentioned text contains your declaration of informed consent sing informations protection. It is indistinguishable to the text on informations protection in the declaration of informed consent which you were given by the research worker.
“ I am cognizant that personal informations, in peculiar medical findings, about my individual will be collected, saved and evaluated during the clinical test. These inside informations about my wellness will be collected and used in conformity with the legal commissariats ; this is capable to my voluntary informed consent prior to the start of the test, i.e. without this consent I can non take portion in the test. ”
Signature of Patient Date ( dd/mm/yyyy ) Printed Name of Patient
Signature of Witness Date ( dd/mm/yyyy ) Printed Name of Witness
Informed consent with respect to informations protection
( Medicines Act )
I agree to the informations collected in the class of the clinical test, particularly informations about my wellness, being recorded on paper and on electronic information bearers. Where necessary, the informations collected may be passed on in pseudonymized signifier ( i.e. coded ) :
to the patron ( Boehringer Ingelheim Pharma GmbH & A ; Co. KG ) or any section commissioned by the latter for the intents of scientific appraisal.
in the event of an application for enrollment: to the applier or a section commissioned by the latter and the regulative authorization ( eg Federal Institute for Drugs and Medical Devices, Bonn ) and the competent international governments.
in the event of inauspicious events and for appraisal of the test consequences: to the patron ( Boehringer Ingelheim Pharma GmbH & A ; Co. KG ) or any sections commissioned by the latter, to the competent Ethics Committees, the competent supervisory governments ( e.g. regional or territory disposal ) the competent federal authorization ( e.g. Federal Institute for Drugs and Medical Devices, Bonn ) , the competent international governments and the European Database.
I besides agree to authorized representatives of the patron ( Boehringer Ingelheim Pharma GmbH & A ; Co. KG ) and the competent national and international supervisory and regulative governments, all punctually sworn to secrecy, inspecting my personal informations available from the research worker, particularly informations refering my wellness, where this is necessary to look into the test is being conducted decently. To this terminal I release the research worker from his duty to detect doctor-patient confidentiality.
The consent to roll up and treat my personal informations, particularly inside informations refering my wellness, is irrevokable. It has already been explained to me that I can retreat from the test at any clip. In the event that I withdraw my consent to take portion in the test, I agree to the informations saved up to that day of the month being used with no reference of my name, where this is necessary to
find the effects of the trial drug,
warrant that my involvements justifying protection are non being violated,
fulfill the duty to subject the complete certification. ”
I agree to my informations being kept for at least ten old ages after expiration or discontinuance of the test, as specified in the commissariats on clinical tests with medicative merchandises. After that period my personal informations will be deleted where there are no opposing legal, constitutional or contractual keeping periods.
I have been informed about the undermentioned legal ordinance: Should I retreat my consent to take portion in the test, all sections that have saved my personal inside informations, particularly inside informations about my wellness, must look into instantly to what extent the saved informations are still required for the intents listed in subdivisions 3a ) to c ) . Any data no longer required must be deleted instantly.
Signature of Patient Date ( dd/mm/yyyy ) Printed Name of Patient
Signature of Witness Date ( dd/mm/yyyy ) Printed Name of Witness
13. Statement of individual carry oning informed consent
I herewith confirm to the best of my cognition that I to the full informed the patient and he/she clearly understands the basic rule of the survey every bit good as the possible hazards and benefits.
Signature of Investigator Date ( dd/mm/yyyy ) Printed Name of Investigator
14. Collection of follow-up information
If I withdraw my consent or am asked by the survey physician to retreat from the survey, I give my permission for the survey material to reach me or person I designate ( e.g. my household physician ) to inquire about my wellness position every three month by telephone ( for the continuance of the survey – approx. one twelvemonth ) . I am still free to retreat this consent at any clip after stating my survey physician. Leaving the survey wholly will non impact my hereafter medical attention.
15. Whom do I inquire if I have farther inquiries?
15.1 Consultation with the trial Centre
You besides have the chance to confer with with your research worker or co-workers if you have any farther inquiries about this clinical test. They will besides be pleased to reply any inquiries sing your rights and duties as a patient and participant in this clinical test.
Name of contact individual: the research worker enters the name of a contact individual here
Telephone figure: the research worker enters the telephone figure of the contact individual here
15.2 Federal contact reference
Persons concerned may besides reach the federal authorization for participants in clinical tests, their legal representatives or proxy about inquiries refering all fortunes of significance for the public presentation of a clinical test.
Bundesinstitut fur Arzneimittel und Medizinprodukte
Fachgebiet Klinische Prufung / Inspektionen
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Telefon: 0228-207 – 4318
Facsimile: 0228-207 – 4355
E-Mail: klinpruefung-bfarm @ bfarm.de
Thank you for holding to take portion in this clinical test ; we hope that with your aid a new, effectual and good tolerated medical specialty will shortly be available for you and many other patients.
15.3 Address, telephone figure of patron and CRO
Contract Research Administration:
PAREXEL International GmbH
Klinikum Westend, Haus 18
Spandauer Damm 130
14050 Berlin
Germany
Tel: +49 30 30685 100 ( cardinal no. )
If you have any farther inquiries about the trial drug which the research worker can non reply, delight make non waver to inquire the patron of this clinical test. The references and telephone Numberss are as follows:
Boehringer Ingelheim Pharma GmbH & A ; Co. KG
Binger Str. 173
55216 Ingelheim
Telephone: 06132 / 770