User's Manual
5-6 Clinical Trials
Introduction to Electronic Signatures
To use Actiware-CT you will be required to log on. The log on procedure is
part of the security Actiware-CT offers to protect the data that is acquired from
Actiwatch.
Each time a record is created or revised, the user must sign with their username
and password and an electronic signature is created and attached to the record.
The electronic signature in Actiware-CT is considered to be the equivalent of a
handwritten signature executed on paper. When the signature process has been
completed, the resulting secure record consists of three parts:
• Data
• Public Key
• Digital Signature
Upon signing and saving the data record, a secret, private key is used to encrypt
a special set of characters that represent the data. This is called a hash, or digest
of the data. The result of this encryption process is the digital signature. The
data in the record is saved along with the digital signature and a public key. The
public key is used to decrypt the digital signature when the record is read. When
the record is read and the signature verified, the result of decrypting the digital
signature (the original hash) is compared to a hash computed from the contents
read from the record. When the two hash results are found to be identical, this
means the signature is verified, and the file has not been altered or corrupted
(including the signature elements that identify the signer: user name and full
name, as well as the public key and digital signature).
Actiware-CT Provision Result
Authentication The identity of the signer can be determined by
anyone.
Integrity Any alteration can be detected.
Non-repudiation Verifies the origin or delivery of data. Protects
the signer because the recipient cannot change
the file. Protects the recipient because the signer
cannot deny they sent it.
Because integrity is assured and authentication and non-repudiation are
provided, the digital signature/public key/user name/full name inserted in every
digitally signed output file can be considered the legally binding equivalent of a
traditional handwritten signature.
Actiware-CT software does not provide the ability to change the contents of an
electronic record that has already been created. Instead, any change to a record
(subject,Actiwatchdata,oranalysis)isrecordedasanewrevisionwithanew
digital signature. Any attempt to change a data record manually will make the
file unusable by the software. Also, each time an electronic record is created, the
user must sign the document, and the user’s user name and full name, along with
date and time of signing are embedded in the record.
Note: Each revision to the data le is preserved and signed/hashed
separately.