Clinical Trials

SOPs and templates for Clinical Trials are found below. This service is currently still being 
updated and expanded, so not all SOPs and their templates are available at this time. 

Further SOPs concerning Pharmacovigilance will continue to be added through 2011.


Background

Clinical and pre-clinical research in the pharmaceutical industry is aimed at developing new drugs, 
including new active substances, new combinations of active substances, new application forms 
and new indications for existing drugs. All new drugs launched onto the market must first be tested 
for safety and efficacy in clinical trials. Clinical trials require careful planning, execution and 
analysis, all in compliance with national and international regulations. Such clinical projects often 
involve complex interactions between sponsors, contract research organisations and regulatory 
authorities and encompass important issues such as patient safety, patient information and 
insurance. It is important to have SOPs in place that guide the efficient management of such clinical 
trial projects within a sponsor's organisation to ensure high-quality output (e.g. data quality) from 
such projects.


Booking

You can order SOPs and associated templates via the order form. After you placed your 
order, we will send a CD-ROM with the chosen documents. With opening the CD box, you agree 
on the purchase.

Please keep in mind that you can only order a Template if you also ordered the associated SOP.

The prices displayed below are applicable ONLY to marketing authorisation holders
and sponsors of clinical trials. Prices for service providers can be requested directly 
from BPI Service zu erfragen.


Description of SOPs and associated Templates
Clinical Trials (English)
Below you will find brief descriptions of all SOPs and Templates in English language that are currently offered by the BPI Service GmbH on the topic of 'Clinical Trials'. The document IDs correspond to the numbers in the order form. In parentheses you will find the prices of the documents.
 
KliFoSOP02EN - Clinical Project Management (250,-€)
Template for a core project management SOP for clinical trials defining the key activities for the planning, execution and completion of a clinical trial project.
 
 
KliFoTPL02EN - Project Plan (90,- €)
Template for generating a study-specific project plan.

Templates can only be ordered when ordering the associated SOP.
 
KliFoSOP02EN - Monitoring in Clinical Trials (250,-€)
This SOP describes the processes for monitoring clinical trials, including risk analysis, the monitoring plan and monitoring reports.
 
 
KliFoTPL23EN - Monitoring Risk Assessment Tool (25,- €)
This worksheet allows the project manager to assess the necessary scope and intensity of the monitoring activities for a clinical trial.

Templates can only be ordered when ordering the associated SOP.
 
 
KliFoTPL26EN - Monitoring Plan (120,-€)
This is a template for generating a study-specific monitoring plan in conjunction with the monitoring risk assessment tool.

Templates can only be ordered when ordering the associated SOP.
 
 
KliFoTPL17EN - Qualification Monitoring Visit (40,- €)
This template is a checklist for a qualification visit at a clinical trial site and may also be used as a monitoring report for the visit.

Templates can only be ordered when ordering the associated SOP.
 
 
KliFoTPL18EN - Initiation Monitoring Visit (40,- €)
This template is a checklist for an initiation visit at a clinical trial site and may also be used as a monitoring report for the visit.

Templates can only be ordered when ordering the associated SOP.
 
 
KliFoTPL19EN - Routine Monitoring Visit (40,- €)
This template is a checklist for a routine monitoring visit at a clinical trial site and may also be used as a monitoring report for the visit.

Templates can only be ordered when ordering the associated SOP.
 
 
KliFoTPL20EN - Close-out Monitoring Visit (40,- €
This template is a checklist for an close-out visit at a clinical trial site and may also be used as a monitoring report for the visit.

Templates can only be ordered when ordering the associated SOP.
 
 
KliFoTPL24EN - Site Monitoring Log (40,- €)
This Log tracks the monitoring visits at a single site during a clinical trial.

Templates can only be ordered when ordering the associated SOP.
 
 
KliFoTPL23EN - Site Preparation Checklist (25,- €)
This template helps a clinical trial site prepare for a monitoring visit.

Templates can only be ordered when ordering the associated SOP.