Enrollment documentation requirements

Methadone generally lasts about one day in the body, meaning that a person in a maintenance program has to take methadone at least once a day. Federal regulations require that to be eligible for enrollment in a methadone maintenance program, potential patients must be at least 18 years of age and demonstrate that they have had at least a one-year history of heroin (or other opiate) addiction. An exception is made for patients between the ages of 16 and 18 who can document a history of at least two unsuccessful detoxification trials. 

Submit the protocol, information sheet and consent form, and other required documentation, to an ethics committee/IRB for review and approval before the study begins. During the study, the investigator is also responsible for submitting any new information, for example protocol amendments, safety information, which might be important for continuing risk assessment by the ethics committee/IRB Obtain informed consent from each study subject prior to enrolment into the study... 

The PI is responsible for maintaining records associated with the clinical study. These include case histories designed to record all observations or other pertinent data on each enrolled subject, independent of whether the subject received active treatment. Data for each trial subject is normally recorded on a case report form provided by the sponsor. The sponsor may also require study data to be recorded in a source document (patient chart). It is the responsibility of the PI to assure that the forms are filled out with the correct information and according to guidelines established by the sponsor. 

Companies have their own processes for patient enrollment that typically require the completion of an application and a reporting of the patient s health insurance coverage, assets, income, and liabilities. A prescription for the medication is usually required. Many programs allow enrollment over the phone, while others require written correspondence. In order to determine eligibility, many companies require verification of a patient s financial status by documents such as income tax returns, W-2 forms, social security and other benefit... 

The CAST was initiated by the NIH in 1987 to determine if suppression of ventricular ectopy with encainide, flecainide, or moricizine could decrease the incidence of death from arrhythmia in patients who had suffered an MI. Entrance criteria included documented MI between 6 days and 2 years prior to enrollment and six or more PVCs per hour without runs of ventricular tachycardia greater than 15 beats in length. Also, patients were required to have an ejection fraction of 55% or less if recruited within 90 days of MI or 40% or less if recruited 90 days or more after MI. Patients with an ejection fraction of less than 30% were randomized only to encainide or moricizine. Patients were randomized to receive drug therapy or placebo after demonstrating PVC suppression with one of the agents. The drug and dose were determined during an open-label dose-titration phase that preceded randomization. 

A total of 44 women with an average age of 58 years were enrolled. Bilateral lesions were present in all patients. Bone metastases were present in 30 patients (63%). Liver-related symptoms were reported in all patients. The average dose of radiation administered was 2.1 GBq (56 mCi). All patients reported mild to moderate postembolization syndrome of nausea, vomiting, fever and mild upper quadrant pain, which was treated symptomatically. Only eight patients required hospitalization for more than 1 night for pain control or dehydration. Grade 3 toxicities of nausea and vomiting were present in seven patients. Two patients had documented stomach ulcers. No deaths attributable to the procedure occurred. 

The MADIT II trial addressed some of the issues raised by the MADIT. The MADIT II trial evaluated patients with ischemic cardiomyopathy (history of myocardial infarction > 1 month before entry). New York Heart Association Functional Class I-III congestive heart failure, and left ventricular ejection fraction < 0.30 (documented within 3 months), with or without ventricular ectopy. The study enrolled 1,232 patients to assess if an ICD improve total mortality compared to optimal therapy alone. No Holter or electrophysiology test criteria were required for enrollment. Optimal medical therapy included angiotensin-converting-enzyme inhibitors, beta-blockers, diuretics, and lipidlowering statin drugs (172). 

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