This is the SOP where I would find directions for creating a new SOP.

The law governing the required elements captured on a sample request/receipt.

This refers to the documented amount of product that the Company deems to be substantial for purposes of reporting under PDMA.

These are two types of Random Audits

One would reference this SOP if looking for inormation regarding the CIA.

The title of the person who has final approval of all SOPs for Sample Compliance

The frequency at which third party audits are conducted.

This is what a rep must do immediatly upon discovering a sample theft.

A document that is required to be completed by the brand manager on an annual basis and updated as there are changes to sampling programs or when new programs are added.

One would reference this SOP if looking for information regarding fair market hospital access fees for reps.

This is where you would look to see the changes that have taken place for each version of an SOP.

This refers to the data review process that is conducted by contracted vendor for all sample activities within the sample inventory period to verify that all sample data has been properly submitted prior to running reconciliation reports.

Upon becoming aware of a reportable incident, Sample Complinace has this many days to file an initial report to the FDA.

A fee paid to an institution or third party vendor for background checks and other activity to qualify a person to enter a designated facility.

One would reference this SOP if looking for information regarding Group 1 Violations.

According to SOPs effective May 1, 2014, data is now required to be stored for this many years.

The term used for samples that are lost by the carrier while being transported.

Samples suspected of improper storage will result in this.

This is a formal letter addressed a to Sales Representative from the District Manager that pertains to Compliance Violations and/or to Group I violations.

One would reference this SOP if looking for information regarding third parties who provide storage and distribution of Company prescription drug samples in accordance with the PDMA.

The length of time Sample Compliance has to receive, review and provide sample data requested by any government agency.

This refers to samples that cannot be accounted for through the inventory process, casual loss or natural disasters.

This training must be taken by all field personnel, Sample Compliance personnel, selected contractors and any others determined by Sample Compliance.

This state requires a mid-level practitioner to provide supervising physician name when signing for samples.

One would reference this SOP if looking for the required elements of a sample request form.