- What is ShareCRF?
ShareCRF is a cloud computing platform to create and manage either clinical trials, observational studies or patient registries.
ShareCRF is a Web-Saas service (Web-software As A Service), which provides 2 main benefits:
- The user just needs any current web browser (Internet Explorer, Firefox, Chrome, Safari) and an internet connexion to be able to use ShareCRF.
- The user does not need any kind of infrastructure or technical knowledge to get access to the platform, everything is hosted in the cloud and ready to be used.
- What do I need to use ShareCRF?
The only item needed to use ShareCRF is an electronic device (computer, tablet, smartphone,...etc) with access to the internet and a current web browser (Internet Explorer, Firefox, Chrome, Safari).
- Is there any additional software installation needed to use ShareCRF?
There is no need to install any software on your devices where you wish to use ShareCRF.
- Does it work in tablets and mobile phones?
ShareCRF was built following the Mobile First Strategy, therefore, ShareCRF works perfectly in tablets, smartphones and computers.
- Who is allowed to create trials in ShareCRF?
Any entity, company or person are allowed to create trials in ShareCRF. When you sign up on ShareCRF platform, you will not have the privileges to create trials yet, but you will be able to be involved in other trials created previously. If you would like to have the privileges required to create trials, you will need just to request it via email to the following email address infoatsharecrf.com and we will provide your user the right privileges with no extra cost.
- Can I try ShareCRF platform?
Of course. The only thing you need to do is to sign up in ShareCRF.com and will be able to check the platform out without strings or cost. A quick reminder, if you wish to create any trial, just send us an email to infoatsharecrf.com and we will provide the right privileges to you.
- Do I need to have a server o technical members to use ShareCRF?
No. ShareCRF platform frees our clients from any technical installation and maintenance, therefore there is no need for our clients to have their own servers or technical people.
- ¿Is ShareCRF secure?
ShareCRF takes security as the main priority for the entire platform. Every single communication with the platform gets encrypted following the certificate RSA 2048 bits(SHA2-256) and the advanced settings to achieve the highest score A+ in the SSL Labs security test.
- ¿Whare are the servers that ShareCRF uses based?
ShareCRF uses as an infrastructure provider AWS (Amazon Web Services) and the data centres where the servers are located are in the European Union.
- ¿Are there any backups?
Of course. ShareCRF creates daily backups stored safely in multiple data centres in the European Union.
- ¿Will we meet the GDPR requirements with ShareCRF?
Yes, ShareCRF allows you to comply the GDPR requirements. The platform has been designed and built following the GDPR higher security standards required.
- ¿Does ShareCRF meet the FDA:21 CFR Part 11 and ICH:GCP requirements?
Yes, ShareCRF meets the data security and integrity requirements. ShareCRF has an inbuilt control security system that allows compliance of validation requirements and meets the FDA requirements for 21 CFR Part 11 and ICH for GCP. ShareCRF has an in-built audit trail system too that records any history data change, user access system with user and password uniques and digital signature mechanisms.
- Is there any guarantee that I will be able to access and manage the data of my trial?
Yes, as a data owner, you will have any time access to manage and download the data of your trial. This will just happen while the associated subscription to that trial is active (or during the 30 days testing period).
Features / Characteristics
- Can be defined different level of access for users?
Yes, ShareCRF allows to set up per trial different user profiles and decide which permissions will have each of them.
- Are the researches allowed to access others researcher's patients?
This functionality relies on how the roles are set up and what permissions are selected per role. The platform allows to set up different kind of roles with associated permissions per trial in which you will be able to decide if for each role the researcher will have access to others researcher's patients or will not have that access. ShareCRF allows independent configurations to be able to meet your requirements per trial, allowing you to define what type of access will have each user to the trial's data.
- Can you create data Queries?
Yes, data queries can be created (discrepancy notes) in two different ways and they can be combined in the same trial:
- Manually created by a user with the right permissions to do so.
- Automatically following a certain number of conditions that appear in the patient's data.
- What available formats can the data be exported into?
The data can be exported in CSV format which can be imported in multiple programs like Microsoft Excel and also can be exported in SPSS and SAS formats, completely ready to start working with the data in the statistical programs.
- Once the trial has kicked off, is there any chance to add either new rules or variables to the CRF?
Of course. We can also provide an incredible test environment where will be possible to validate the changes made on the CRF before they are published to the rest of the users. With this, you will be able to validate exactly the changes made and how they will affect the entire CRF before integrating them in the production environment.
Payment and subscription
- What is the ShareCRF payment policy?
Each study has a paid subscription associated. The subscription can be paid either monthly o annually at the beginning of each subscription period. The subscriptions will renew automatically and also their payment will be collected automatically as well for your convenience.
- What is the ShareCRF payment method?
The ShareCRF main payment method is by credit/debit card. We use the services provided by Stripe to charge by card, one of the most important and reliable companies in the online payment sector. Therefore, we do not store any of our client's credit/debit card details.
- Are bank transfers allowed as a payment method?
Yes, we also accept payment by transfer for amounts over € 1,500. Once we have received the bank transfer, we will add the amount to the user's account as a ShareCRF credit that can be used to pay for the subscriptions of their studies.
Contact us via email on the following email address infoatsharecrf.com if you would like to proceed with this payment method and we will inform you about the steps to follow, solving any kind of question that you could have.
- What is the ShareCRF credit?
ShareCRF credit is a type of currency associated with each user that is used as a priority way for the payment of the ShareCRF subscriptions. There are 2 different ways to get ShareCRF credit:
- Payment with bank transfer.
- Automatic adjustment when the user changes the current trial subscription to a cheaper one. In this case, ShareCRF generates a credit for the client apportioning both subscriptions.
- How many studies can I create in ShareCRF?
There is no limit of studies that you can create. Each trial has an independent subscription associated.
- Do all study subscriptions cost the same?
No, the subscriptions have different prices based on 2 different factors:
- Type of subscription selected.
- Maximum number of Records that are allowed in the study.
The type of subscription sets the different group of features that you would be available to use on the study. There are 4 types of subscription to suit your study requirements.
- Advanced Plus
- Can I change either the subscription type or the maximum number of patients whenever I wish?
Yes, ShareCRF allows you to change the type of subscription and/or the number of records at any time, also you would be able to change the time of the subscription between Monthly and Annually at any time.
- What does happen when I change either the subscription type, maximum number of records or time selected for the subscription before finishing the current subscription period?
The system will make a proration to calculate the service consumed by the current subscription and the new one so that the client will only pay for the subscription time used. For example, if in the middle of an annual subscription period you decide to change from a Basic subscription type to a Standard one, the system will calculate that you have 6 months of subscription left and will only charge you the price difference between the Standard and Basic packages for 6 months.
- Do I either have to pay in advance or enter my credit card details to create a new study?
No, ShareCRF offers the first 30 days of each study for free, with no commitments. Once you have finished the registration process in www.sharecrf.com, send us an email to firstname.lastname@example.org, so we will activate your user for free and assign the right privileges that will allow you to create studies.
- What does happen with the trial after the 30 days after creating a study?
If before the trial period expires you have not created a subscription associated with the study, when the expire day arrives, the system will start the process of closing the study automatically. If during that period, you have created a subscription associated with the study, after the expire day arrives, the system will generate a direct debit payment and the trial will continue working with the subscription selected
- What does happen when a subscription plan associated with a study is closed?
For example, when the subscription ends, because the study has ended. From this moment, the access to the study will be blocked to everyone(promoter, creator, researchers, etc). In any case, you can always export the full records database before ending the subscription.
- If I do not have studies with an active subscription associated, do I have to pay something?
No, if you do not have any study with an active subscription, we do not charge anything.
- Can I cancel the subscription anytime?
Yes, the subscription associated with a study can be cancelled at any time. In this case, you can continue accessing the study until the cancellation date of the subscription.
- Do researchers have to pay something to use ShareCRF?
No, the ShareCRF service payment is only associated with the person who creates the study. The rest of the users invited to participate in the study do not have to pay anything.
- Are there any more extra cost associated to the ShareCRF platform?
No, There are no more costs than the one associated with the subscription selected. ShareCRF complementary offers a service of the creation of studies, support and help with data migration process, guidance in the development of advanced solutions, training courses, data recovery under petition and others that may be requested by customers that are not included in the additional services guide. All of them are carried out by our specialized staff and according to the needs of the study and/or client.
- I like ShareCRF but unfortunately do not have the time to configure my own eCRF. Could you do it for me?
Yes of course. ShareCRF offers additional services for the creation of studies in which our specialized staff will configure the study for you.
- I am interested in creating a study. What do I have to do?
First thing to do in order to create a study is to register in ShareCRF platform. You can register through the following link. Once registered, send us an email to infoatsharecrf.com letting us know so we can grant you permission to create studies and from that moment you will be able to create new studies.
- How can I find out more about the prices of ShareCRF?
If you would like to create an study and want to find more about our prices, send us an email to email@example.com.
- If I have any question/concern about ShareCRF, What should I do?
Send us an email to firstname.lastname@example.org, indicating your phone number if you would like us to call you, we will be happy to help.