DATA MANAGEMENT PLAN Version 1.1

Authorised by:
Name:				Role:
Signature:				Date:
Prepared by
Name:				Role:
Signature:				Date:

1.    Key Personnel

• a section that details the name, their function in the trial, email address, telephone/fax number for all the staff involved in the trial including the sponsor, the project coordinator, the project manager, the investigators, study staff involved in the data management (including computing staff responsibilities for maintaining hardware and software), the monitors and anyone else associated with the trial

2.    Study Milestones

All activities are listed from the protocol development till the end of the study analysis and finalisation of a study report and especially first and last patients enrolled, first and last CRFs sent to the data management, data validated and locked. This includes dates for when key milestones should be and have been reached, and can help to organise day to day data management activities in order to relate them to the planned timelines.
Example

Activity	Planned date	Achieved date
Final protocol
Final CRF
Edit check designed and finalised
Validation checks specified and finalised
Database (field edition) specifications finalised
Database application and testing
First patient's first visit centre X centre XX
First monitoring visit (FMV) centre X centre XX
First CRF in data management centre (LDM) centre X centre XX
Last patient's last visit
Last CRF in data management centre
Last query resolved – data cleaned

3.    Data Flow

• a section that details the flow of the data from the field to the final storage

4.    CRF Completion Guidelines

• a section that details how to complete the paper CRFs or how to enter data electronically. This document will be used to train investigators
• This can be a separate document and included in the DMP as an appendix

5.    Monitoring Plan

• a section that detail the monitoring plan if monitors are involved in the trial. It will detail for example, the frequency of the monitoring visits, how the Source Data Verification will be done, what are the laboratory ranges for verification/clinical interpretation

6.    Data Entry Guidelines

• a section that details data entry
• how to use the data entry system set up?
• double or single data entry?
• what are the role and responsibilities of the study staff? For example, who has the responsibility to for entering the data first, with which computer, who will enter data for the 2nd time? Who will merge the file to check for discrepancies? What are the procedures in case of discrepancy?

7.    Data Edit Checks

• a section that details edit checks (data entry checks and post entering data checks specifications) as described previously in this Session

8.    Coding

9.    Data Validation

• a section that describes the post data entry validation system. With for example:
• who checks the consistency of the data?
• who queries the investigator?
• what is the format of a query form?
• how many days are allowed to answer to a query?
• who decides that a query is resolved?

10. Data Back-up and Archiving

• a section that describe procedures in place to ensure data protection including back-up system (if you don't do this you could lose the data!)

Receiving IMP SOP

Standard Operating Procedure			SOP No: Version: 1 Effective Date:
Title:    Receiving IMP
	NAME	SIGNATURE		DATE
PREPARED BY
REVIEWED BY
QA UNIT AUTHORITY
APPROVAL AUTHORITY

1.       Purpose/scope                                        

To describe the procedureforreceiving Investigational Medicinal Product (IMP) for a clinical trial conducted by the [institution/group], including placing it in quarantine and adding it to the Pharmacy inventory. This procedure may be supplemented with a trial-specific pharmacy manual or process document(s).

2.       Templates/forms                   

IMP01.1               Acknowledgement of Investigational Medicinal Product Receipt

IMP01.2               Pharmacy Accountability Form

3.       Glossary/definitions

See also: South African Good Clinical Practice (SAGCP) Guideline; ICH Guideline for Good Clinical Practice E6; South African Guide to Good Manufacturing Practice and Good Pharmacy Practice

Essential Documents

Documents which individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced (See South African Good Clinical Practice Guideline, Second Edition. 2006. Appendix C).

Good Manufacturing Practice

That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the medicine registration or product specification

Good Pharmacy Practice

Standards developed to ensure that all practising pharmacists and other health care professionals providing medicines provide a service of high quality for the public and private sector alike.

Investigational Medicinal Product (IMP)

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Investigator Site File (ISF)

Files of Essential Documents held by the Investigator. NB on occasion the [institution/group]may also hold the Sponsor's Essential Documents in a Trial Master File, where the Principal Investigator (PI) assumes a Sponsor-investigator role.

4.       Responsibilitiesand procedure

If the trial is conducted outside of [institution/group]facilities the place where IMP is to be stored (pharmacy or otherwise) should, similarly, be suitable in terms of access control, capacity and equipment (e.g. for temperature monitoring).

Should the IMP involve re-packaging of bulk supplies for individual participants, contact the CRC for advice about whether there is a requirement to comply with regulations over and above Good Pharmacy Practice (e.g. Good Manufacturing Practice).

4.1.   Acknowledgement of IP receipt:

4.1.1.      Arrangements for delivery or collection of IMP are made with the supplier such that its integrity is maintained throughout the transport process.

4.1.2.      Upon receipt of IMPs into the pharmacy, the resident pharmacist should notify the trial pharmacist of the delivery. Either the resident or trial pharmacist should acknowledge receipt using the IMP Acknowledgement of Receipt Form (IMP01.1), (or alternative document if required by Sponsor), sending the form back to the appropriate party as required.A separate IMP01.1 is completed for each type and batch of IMP, being as specific as possible while maintaining the integrity of the packaging.

4.1.3.      All documentation accompanying or detailing the delivery are noted and filed in the Pharmacy file and/or Investigator Site File (ISF). This may include package inserts, certificates of compliance with GMP Guidelines, certificates of analysis (test products), or product release certificates (reference products). If any expected documents are missing, adesignee must notify the pharmacy or Sponsor without undue delay.

4.1.4. If the IMP cannot be immediately added to the pharmacy inventory, it should be labelled with the protocol number, date of receipt and the word “QUARANTINE”.

4.1.5. As soon as the IMP arrives, protocol-specific processes relating to storage of the IMP, such as temperature monitoring, will be commenced.

4.2.   Initial IP accountability:

4.2.1.      IMP is added to the pharmacy inventory using an accountability form (IMP01.2). 

4.2.2.      Work with one type of IMP at a time on a clear, clean surface, taking into account what is known about its toxicity, potency, sensitising potential and risk of cross-contamination.Ensure that audited/un-audited stock is kept separate to avoid confusion.

4.2.3.      If there is more than one container of the IMP, ensure expiry dates/batch numbers are the same on each (if different, consult the investigator to ascertain if this is acceptable).

4.2.4.      First establish visually if the product on the data sheet appears to be what is supplied. Where containers are received sealed, cross-check labels with the delivery documentation. Ensure details on any outer boxes correlate with wrapping inside the box and that, for instance, blisters are filled appropriately. Where containers are received unsealed, use a clean pill tray or weighing machine (or other equipment depending on the formulation) to verify the contents; count or weigh the IMP ensuring it is consistent in appearance (e.g. colour, size and integrity). The total should be double-checked by the same person or another member of the team.

4.2.5. Any deviations between forms IMP01.1 and 2 should be explored anddocumented.

4.3.    Should members of the trial team need to be blinded to any of the above procedures, this should be documented in detail in a Pharmacy Manual or other trial-specific document.

5.       Document history:

Version No.	Date	Reviewer	Details of changes

INVESTIGATIONAL DRUG ACCOUNTABILITY RECORD

Sponsor Name :							Protocol No:
Investigator  :							Total Quantity Received/Date         : (including Replacement kits)
Center code :  N/A							Test Drug:
Study site Name :							Batch No.    :  Batch No.    :
							Mfg Date     :  Mfg Date     :
							Expiry Date :  Expiry Date :
Study Title
Subject initials	Subject ID	Drug Kit Number	Visit	Date dispensed	Dispensed By/Initials	Date Returned		Amount of Drug present	Site personnel Signature	CRA/Monitor Signature