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Standard Operating Procedures
- Series 000: General
- Series 100: Health Authorities/Ethics Committees/Regulatory
- Series 200: Monitoring
- Series 300: Project Related Documents
- Series 400: Data Management/Biometrics
- Series 500: Pharmacovigilance/Quality Assurance
- Series 600: Customer Relations
- Series 700: Human Resources
- Series 800: Administration/Finance
- Series 900: Others
SERIE 000: GENERAL (3)
| Reference | Title |
|---|---|
| PIVO-001 | Standard operating procedures development: SOP of SOPs |
| PIVO-002 | Global quality system and standards reference guideline |
| PIVO-003 | Good Documentation Practices |
SERIE 100: HEALTH AUTHORITIES/ETHICS COMMITTEE/REGULATORY (6)
| Reference | Title |
|---|---|
| PIVO-101 | Auth CT in Spain (EC) |
| PIVO-102 | Auth CT in Spain AEMPS |
| PIVO-103 | Granting and maintenance a PEI qualification |
| PIVO-104 | Financial Disclosure |
| PIVO-105 | Notification to Authorities-EC |
| PIVO-106 | Obtaining an authorisation to conduct post authorization clinical trials |
SERIE 200: MONITORING (12)
| Reference | Title |
|---|---|
| PIVO-201 | Pre-study site visits |
| PIVO-202 | Initiating the study site |
| PIVO-203 | Monitoring the study site: source data verification |
| PIVO-204 | Closing the study site |
| PIVO-205 | Investigational product: shipment, accountability and return, destruction or transfer |
| PIVO-206 | Clinical research associate and investigator responsibilities |
| PIVO-207 | Monitoring plan |
| PIVO-208 | Investigator meetings |
| PIVO-209 | Study payment management |
| PIVO-210 | Return of all unused material to client |
| PIVO-211 | Monitors internal pre-study meeting |
| PIVO-212 | Handing over of responsibilities when changing monitors in a specific study |
SERIE 300: PROJECT RELATED DOCUMENTS (16)
| Reference | Title |
|---|---|
| PIVO-301 | Selecting investigators and sites |
| PIVO-302 | Collecting and archiving essential documents |
| PIVO-304 | Clinical study protocols/amendments: design and management |
| PIVO-305 | Literature review |
| PIVO-306 | Consulting on project design |
| PIVO-307 | Translation of documents |
| PIVO-309 | Preparation of protocol outline for clients |
| PIVO-310 | Preparation of patient information and informed consent form |
| PIVO-311 | Insurance certificate |
| PIVO-313 | Study contract: centre and investigator |
| PIVO-314 | Project management, organization, planning and coordination |
| PIVO-315 | Development, approval and distribution of the clinical study reports and abbreviated clinical study reports. |
| PIVO-316 | Medical publications |
| PIVO-317 | Observational post-authorization studies: design and management |
| PIVO-318 | Advisory boards management |
| PIVO-319 | Trial Master File preparation |
SERIE 400: DATA MANAGEMENT & BIOSTATISTICS (29)
| Reference | Title |
|---|---|
| PIVO-401 | Case report form design |
| PIVO-402 | Coding process |
| PIVO-403 | Creating and testing of the database |
| PIVO-404 | Preparing the Data Plan Management |
| PIVO-405 | Data entry |
| PIVO-406 | Maintenance of data coding dictionaries |
| PIVO-407 | Case report forms transmission and reception |
| PIVO-408 | Handling and storage of case report forms within clinical data management |
| PIVO-409 | Making data corrections |
| PIVO-410 | Database finalization and locking (including re-opening) |
| PIVO-411 | Data management quality control activities |
| PIVO-414 | Data cleaning & data clarification form processing |
| PIVO-415 | Electronic case report forms creation |
| PIVO-417 | DM & BS File management |
| PIVO-418 | Lab normal ranges management |
| PIVO-419 | Reading and writing external data |
| PIVO-420 | Data Transfer bacn to the Sponsor |
| PIVO-421 | e-Randomizer |
| PIVO-451 | Design and writing the statistical section of a protocol. Sample size calculation |
| PIVO-452 | Preparing the statistical analysis plan |
| PIVO-453 | SAS database creation and transfer |
| PIVO-454 | Statiscal programming |
| PIVO-455 | Patient profiles programming and generation |
| PIVO-456 | Blind data review meeting |
| PIVO-457 | Statistical reports: intermediate and final |
| PIVO-458 | Quality control of clinical study reports |
| PIVO-459 | Randomisation of clinical studies |
| PIVO-460 | Validating SAS programs |
SERIE 500: PHARMACOVIGILANCE/QUALITY ASSURANCE (8)
| Reference | Title |
|---|---|
| PIVO-506 | Scientific misconduct and fraud |
| PIVO-508 | Spontaneous Adv Drug Reaction Pos-Auth studies |
| PIVO-509 | Writing periodic safety evaluations |
| PIVO-510 | Audit and inspections |
| PIVO-511 | Quality deviation management |
| PIVO-512 | Managing serious adverse events and pregnancy notifications from clinical trials with Pharmacovigilance activities not delegated in Pivotal |
| PIVO-513 | Clinical trials with Pharmacovigilance delegated in Pivotal |
| PIVO-551 | Conducting audits by QA |
SERIE 600: CUSTOMER RELATIONS (3)
| Reference | Title |
|---|---|
| PIVO-601 | Contracts management |
| PIVO-602 | Confidentiality agreement |
| PIVO-604 | Evaluation of client satisfaction |
SERIE 700: HUMAN RESOURCES (5)
| Reference | Title |
|---|---|
| PIVO-703 | Track IT |
| PIVO-704 | Working calendar, holidays, days off |
| PIVO-705 | Training |
| PIVO-707 | Privacy |
| PIVO-708 | JD&CV |
SERIE 800: ADMINISTRATION/FINANCE (2)
| Reference | Title |
|---|---|
| PIVO-801 | Purchases to be included in inventory |
| PIVO-802 | Travel expenses procedure |
SERIE 900: OTHERS (7)
| Reference | Title |
|---|---|
| PIVO-901 | Data backups |
| PIVO-902 | Information technologies disaster recovery plan |
| PIVO-903 | Users accounts management |
| PIVO-904 | Issues management |
| PIVO-905 | Computer System Validation |
| PIVO-906 | Secure electronic transmission |
| PIVO-908 | Computer Validated systems maintenance |
