Relating to the Review of Consulting Activities. a. a description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity; b. for each Consulting Activity reviewed, the IRO's findings and supporting rationale as to whether: i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant; ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by RMS; iii. the rate structure was established based on an independent FMV analysis; iv. the Consulting Activity was identified in the annual Consulting budgeting plan developed by RMS; v. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity; vi. the Consulting Activity was reviewed and approved in accordance with RMS Policies and Procedures, vii. RMS collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated in connection with the Consulting Activity; and viii. the activity undertaken by the Consultant and/or the work product generated was used by RMS in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity; c. any weaknesses in RMS’s systems, processes, policies, procedures and/or practices relating to Consulting Activities identified by the IRO; and d. any recommendations for improvements to RMS's systems, processes, policies, procedures and/or practices relating to Consulting Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Relating to the Review of Consulting Activities.
a. a description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity;Activity;
b. for each Consulting Activity reviewed, the IRO's findings and supporting rationale as to whether:whether:
i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant;
ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by RMSLife Spine;
iii. the rate structure was established based on an independent FMV analysis;
iv. the Consulting Activity was identified in the annual Consulting budgeting plan developed by RMS;Life Spine;
v. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity;Activity;
vi. the Consulting Activity was reviewed and approved in accordance with RMS Life Spine Policies and Procedures,
vii. RMS Life Spine collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated in connection with the Consulting Activity; and
viii. the activity undertaken by the Consultant and/or the work product generated was used by RMS Life Spine in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity;
c. any weaknesses in RMSLife Spine’s systems, processes, policies, procedures and/or practices relating to Consulting Activities identified by the IRO; andand
d. any recommendations for improvements to RMSLife Spine's systems, processes, policies, procedures and/or practices relating to Consulting Activities.Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Relating to the Review of Consulting Activities.
a. a description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity;Activity;
b. for each Consulting Activity reviewed, the IRO's findings and supporting rationale as to whether:whether:
i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant;
ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by RMSMerit;
iii. the rate structure was established based on an independent FMV analysis;
iv. the Consulting Activity was identified in the annual Consulting budgeting plan developed by RMS;Merit;
v. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity;Activity;
vi. the Consulting Activity was reviewed and approved in accordance with RMS Merit Policies and Procedures,
vii. RMS Merit collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated in connection with the Consulting Activity; and
viii. the activity undertaken by the Consultant and/or the work product generated was used by RMS Merit in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity;
c. any weaknesses in RMS’s Merit's systems, processes, policies, procedures and/or practices relating to Consulting Activities identified by the IRO; andand
d. any recommendations for improvements to RMSMerit's systems, processes, policies, procedures and/or practices relating to Consulting Activities.Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Relating to the Review of Consulting Activities.
a. a description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity;Activity;
b. for each Consulting Activity reviewed, the IRO's findings and supporting rationale as to whether:whether:
i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant;;
ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by RMS;Merit;
iii. the rate structure was established based on an independent FMV analysis;;
iv. the Consulting Activity was identified in the annual Consulting budgeting plan developed by RMS;Merit;
v. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity;Activity;
vi. the Consulting Activity was reviewed and approved in accordance with RMS Merit Policies and Procedures,,
vii. RMS Merit collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated in connection with the Consulting Activity; andand
viii. the activity undertaken by the Consultant and/or the work product generated was used by RMS Merit in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity;;
c. any weaknesses in RMS’s Merit's systems, processes, policies, procedures and/or practices relating to Consulting Activities identified by the IRO; andand
d. any recommendations for improvements to RMSMerit's systems, processes, policies, procedures and/or practices relating to Consulting Activities.Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Merit Medical Systems Inc)
Relating to the Review of Consulting Activities.
a. a description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity;Activity;
b. for each Consulting Activity reviewed, the IRO's findings and supporting rationale as to whether:whether:
i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant;
ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by RMS;
iii. the rate structure was established based on an independent FMV analysis;
iv. the Consulting Activity was identified in the annual Consulting budgeting plan developed by RMS;RMS;
v. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity;Activity;
vi. the Consulting Activity was reviewed and approved in accordance with RMS Policies and Procedures,
vii. RMS collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated in connection with the Consulting Activity; and
viii. the activity undertaken by the Consultant and/or the work product generated was used by RMS in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity;
c. any weaknesses in RMS’s systems, processes, policies, procedures and/or practices relating to Consulting Activities identified by the IRO; andand
d. any recommendations for improvements to RMS's systems, processes, policies, procedures and/or practices relating to Consulting Activities.Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Ra Medical Systems, Inc.)
Relating to the Review of Consulting Activities. In connection with the review of Consulting Activities:
a. a A description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity;
b. for each Consulting Activity reviewed, the The IRO's ’s findings and supporting rationale as to whether:
i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant;
ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by RMSACell;
iii. the rate structure was established based on an independent a FMV analysisanalysis conducted by or for ACell;
iv. the Consulting Activity was identified in the annual Consulting budgeting plan developed by RMS;ACell;
v. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity;
vi. the Consulting Activity was reviewed and approved in accordance with RMS ACell Policies and Procedures,;
vii. RMS ACell collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated in connection with the Consulting Activity; andActivity;
viii. the activity undertaken by the Consultant and/or the work product generated was used by RMS ACell in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity;
c. ix. the IRO identified any weaknesses in RMSACell’s systems, processes, policies, procedures and/or practices relating to Consulting Activities identified by the IROActivities; and
d. any x. the IRO has recommendations for improvements to RMS's ACell’s systems, processes, policies, procedures and/or practices relating to Consulting Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement