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:
a) Texas Code of Criminal Procedure, Chapter 46B.
b) Texas Health and Safety Code, Chapter 574.
c) 25 TAC, Chapter 405, Subchapter K, in its entirety.
d) 25 TAC, Chapter 414, Subchapter I, in its entirety.
e) 25 TAC, Chapter 414, Subchapter K, in its entirety.
f) 25 TAC, Chapter 414, Subchapter L, in its entirety.
g) 25 TAC, Chapter 415, Subchapter A, in its entirety.
h) 25 TAC, Chapter 415, Subchapter F, in its entirety. i) 26 TAC, Chapter 306, Subchapter A, in its entirety.
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. 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. Drug Accountability
Treatment Compliance. All doses of the study drug will be administered in the study site under direct observation of study site personnel and recorded in the eCRF. Per standard clinic procedure, study site personnel will perform a mouth check and inspect all dose containers to ensure that the entire dose was administered. Following completion of dosing procedures and return of dosing containers to the pharmacy by team members, pharmacy staff will follow standard clinic procedures for study drug reconciliation. SIGA will provide information to PPD for destruction of returned used and unused study drug and study drug bottles. The date and time of study drug dosing will be captured and recorded on the appropriate page of the eCRF. If a subject is not administered study drug, the reason for the missed dose will be recorded.
Treatment Compliance. Compliance for doses taken outside of the clinic may be assessed by the return of study drug to the study site and review of doses taken with the subject (or guardian). This will be recorded in the source documents, which may include the use of a subject medication diary per institutional practice.
Treatment Compliance. LJPC-501 will be administered to eligible patients by a qualified healthcare professional under the supervision of either the Investigator or Sub-Investigator(s). The pharmacist will maintain records of LJPC-501 receipt, preparation, and dispensing, including the applicable lot numbers, and the patient’s body weight.
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. 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.
