Treatment Compliance. The study site personnel will perform drug accountability at each clinic visit and review each subject diary (refer to Section 7.1.16). Accountability will be documented on the appropriate forms and subjects will be re-trained on administration as appropriate. All doses of study medication are to be self-administered. If a subject does not administer or take all study medication including vitamin D or calcium, the reason for the missed dosing is to be recorded in source documents and on the eCRF. Returned, unused alendronate will be accounted for by the study site and destroyed as appropriate.
Treatment Compliance. Provide treatment services in accordance with all applicable federal or state laws, rules, regulations, standards and guidelines, as amended, including but not limited to, the following:
Treatment Compliance. In order to evaluate the safety, efficacy and tolerance of BA058 80 µg, it is critical that patients comply with the treatment regimen to which they were randomized and honor the schedule of visits and procedures required by the study. Patient compliance will be ascertained by three methods: patient diaries, cartridge accountability, and site-assessment of remaining drug content of returned cartridges. The location, date and time that each dose of study medication was administered will be recorded in a patient diary for the first 30 days of treatment for review at the Month1 (Visit 4), and for the 30 days of Month 11 for review at the Month 12 (Visit 8) study visit, and entered in the appropriate case report form. Weekly summaries of study drug administration will also be maintained by the patient throughout the study. All doses of study medication are to be self-administered or administered by an individual trained in giving the injection (e.g., a family member). Study personnel may administer the injection on days of clinic visits. If a patient does not take all study medication (BA058 80 µg, Placebo, teriparatide, Calcium and Vitamin D supplements), the reason for the missed dosing is to be recorded in source documents and on the appropriate case report form. During the Follow-up Period, it is recommended that patients continue taking the Calcium and Vitamin D supplements, but treatment compliance will not be assessed during this post-treatment period. The residual volume of returned cartridges will be measured by the height of the fluid column and recorded in source documents and on the appropriate case report form by the site personnel when the cartridge is returned by the patient.
Treatment Compliance. While in the Clinical Research Unit, study treatment will be administered under the supervision of site personnel. Compliance during the non-study visit days will be assessed by subject reporting and pill count. Study personnel should counsel subjects on study medication compliance during each study visit. A qualified designee will be responsible for monitoring the administration of the timed oral doses on study visit days.
Treatment Compliance. While in the Clinical Research Unit, study treatment will be administered under the supervision of site personnel. Compliance during the non-study visit days will be assessed by subject report Confidential Page 8 of 18 investigational product, when appropriate, for each AE (unrelated, possibly related or probably related). The investigator should decide whether, in his or her medical judgment, there is a reasonable possibility that the event may have been caused by the investigational product. If no valid reason exists for suggesting a relationship, then the AE should be classified as “unrelated.” If there is any valid reason, even if undetermined, for suspecting a possible cause and effect relationship between the investigational product and the occurrence of the AE, then the AE should be considered “related.” If the relationship between the AE/SAE and the investigational product is determined to be “possible” or “probable” the event will be considered to be related to the investigational product for the purposes of expedited regulatory reporting. Serious Adverse Events An AE is considered serious if, in the view of either the investigator or sponsor, it fulfills at least one of the following: • Results in death • It is immediately life-threatening • It requires in-patient hospitalization or prolongation of existing hospitalization • It results in persistent or significant disability or incapacity • Results in a congenital abnormality or birth defect • It is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above. Adverse Event Summaries All AEs (serious and non-serious) occurring after completion of the informed consent process and before the end of study, regardless of relationship to study drug, will be included and classified by SOC and PT using the Medical Dictionary for Regulatory Activities (MedDRA). For treatment-emergent AEs (TEAEs), the following will be summarized and presented for the safety analysis set:
Treatment Compliance. The investigator or his/her designated and qualified representatives will only dispense study drug to patients enrolled in the study in accordance with the protocol. The study drug must not be used for reasons other than that described in the protocol. Patients who miss more than 42 doses (i.e., 25% of the 168 expected doses) will not be considered treatment-compliant. Patients must be considered treatment-compliant to be eligible for the open-label extension study.
Treatment Compliance. Drug Accountability The Investigator is accountable for all clinical drug supplies shipped to his/her study site for the duration of the study. A final accounting of the clinical drug supplies will be required at the completion/termination of the study. The Investigator is required to provide written explanation for any discrepancies. All used and unused clinical drug supplies will be inventoried and returned to the Sponsor (or an authorized representative) by a designated monitor.
Treatment Compliance. Study drug will be dispensed by the site. Study drug administration will be monitored via a follow-up call from the site each evening (within approximately 1 hour following the scheduled evening dose) on Days 1-14. Any reasons for noncompliance will be documented, including: • Missed visits; • Interruptions in the schedule of administration; and • Nonpermitted medications. The time at which study procedures are conducted should follow the protocol timelines as closely as possible.
Treatment Compliance. Unit members are encouraged to make use of the available resources for treatment for substance abuse problems. As provided in this Article, a unit member may be required to undergo treatment for substance abuse. A unit member who refuses or fails to comply with the requirements for treatment, after care, return to duty, or follow-up testing shall be subject to termination.
