Dear Dr. {{$doctorName}},
Subject: In-Practice Usage and Performance (IPUP)Study of R4CLEAR;
Study code: IPUP/R4CLEAR/Chest Physician/Pharma care/Oct 2023.
R4CLEAR is a combination of Acebrophylline 100mg & N Acetyl cysteine 600 mg for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
R4CLEAR a combination of Acebrophylline 100mg & N Acetyl cysteine 600 mg is marketed by the ‘Pharma care’ team of Sun Pharmaceutical Industries Ltd.
Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planned to conduct a cross sectional study to assess the real-life performance of ‘R4CLEAR’ in patient’s with COPD.
We invite you to participate in this study. All you need to do is to report on a standard form your experience with ‘R4CLEAR’ in 6 consecutive patient’s (to avoid any bias) in whom you prescribe this product in the normal course of your practice. Thus, this is not an experimental study because the product will be prescribed and purchased as you and your patient’s normally do.
If you agree to participate, you will need to copy the relevant information from the suggested number of patient’s case papers, and investigational reports, if any (which we call source documents), on to the standard case report forms (which we call CRF).
CRF has to be verified with the source documents to ensure that the CRF signed by you are free from errors or omissions. Let us assure you that the CRF will not contain the patients’ names, so as to ensure confidentiality.
If any serious adverse events (AE) occur during ‘R4CLEAR’ treatment, you will be expected to report them to the monitor or to me immediately on the AE reporting form.
As you will be spending some extra time to keep, copy and verify these patient’s records, we offer to pay you by cheque a professional fee of Rs. {{$contractAmount}}/- .
We trust you and we are partners in promoting safe and effective drug therapy. In that spirit, we hope you will consent to participate in this study. If you do, please sign and return the enclosed reply along with your visiting card for accuracy of records.
Yours truly,
}})
Mr Ambrish Sahai
Sr. General Manager
Pharma care Division
Sun Pharmaceutical Industries Ltd.
Sun House CTS No. 201 B/1,
Western Express Highway,
Goregaon (E),
Mumbai - 400 063
Tel: + 91 22 4324 1234/4324
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